Author: "Bruno Laviolle" / Topic: 03 medical and health sciences - Searchworks@Jio Institute Digital Library Search Results

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63 results on '"Bruno Laviolle"'

1. Enquête sur la certification aux bonnes pratiques cliniques en recherche académique

Author: Elodie Labourdette, Mariella Le Saux, Sabrina Nekmouche, Véronique Lorre, Jimmy Chesnais, Céline Joumard, Claire Fougerou-Leurent, Eric Bellissant, Aurelie Veislinger, Carole Marie, Catherine Bellot, Loïc Fin, Nathalie Alleton, and Bruno Laviolle
Subjects: Protocol (science), medicine.medical_specialty, business.industry, education, Certification, Audit, Certificate, 030226 pharmacology & pharmacy, 3. Good health, Clinical trial, 03 medical and health sciences, 0302 clinical medicine, Clinical research, Quality standard, Family medicine, Good clinical practice, Medicine, Pharmacology (medical), business
Abstract: Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the "Bretagne recherche clinique hospitaliere network": Rennes, Saint-Malo, Saint-Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigators' GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of all physicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals.
Published: 2020
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2. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial

Author: Florence Ader, Maude Bouscambert-Duchamp, Maya Hites, Nathan Peiffer-Smadja, Julien Poissy, Drifa Belhadi, Alpha Diallo, Minh-Patrick Lê, Gilles Peytavin, Thérèse Staub, Richard Greil, Jérémie Guedj, Jose-Artur Paiva, Dominique Costagliola, Yazdan Yazdanpanah, Charles Burdet, France Mentré, Alexander Egle, Michael Joannidis, Bernd Lamprecht, Antoine Altdorfer, Leila Belkhir, Vincent Fraipont, Gil Verschelden, Jérôme Aboab, Hafid Ait-Oufella, Claire Andrejak, Pascal Andreu, Laurent Argaud, Firouzé Bani-Sadr, François Benezit, Mathieu Blot, Elisabeth Botelho-Nevers, Lila Bouadma, Olivier Bouchaud, David Bougon, Kevin Bouiller, Fanny Bounes-Vardon, David Boutoille, Alexandre Boyer, Cédric Bruel, André Cabié, Emmanuel Canet, Charles Cazanave, Cyrille Chabartier, Catherine Chirouze, Raphaël Clere-Jehl, Johan Courjon, Flora Crockett, François Danion, Agathe Delbove, Jean Dellamonica, Félix Djossou, Clément Dubost, Alexandre Duvignaud, Olivier Epaulard, Loïc Epelboin, Murielle Fartoukh, Karine Faure, Emmanuel Faure, Tristan Ferry, Cécile Ficko, Samy Figueiredo, Benjamin Gaborit, Rostane Gaci, Amandine Gagneux-Brunon, Sébastien Gallien, Denis Garot, Guillaume Geri, Sébastien Gibot, François Goehringer, Marie Gousseff, Didier Gruson, Yves Hansmann, Olivier Hinschberger, Stéphane Jaureguiberry, Vanessa Jeanmichel, Solen Kerneis, Antoine Kimmoun, Kada Klouche, Marie Lachâtre, Karine Lacombe, Fabrice Laine, Jean-Philippe Lanoix, Odile Launay, Bruno Laviolle, Vincent Le Moing, Jérôme Le Pavec, Yves Le Tulzo, Paul Le Turnier, David Lebeaux, Benjamin Lefevre, Sylvie Leroy, François-Xavier Lescure, Henry Lessire, Benjamin Leveau, Paul Loubet, Alain Makinson, Denis Malvy, Charles-Hugo Marquette, Guillaume Martin-Blondel, Martin Martinot, Julien Mayaux, Armand Mekontso-Dessap, Ferhat Meziani, Jean-Paul Mira, Jean-Michel Molina, Xavier Monnet, Joy Mootien, Bruno Mourvillier, Marlène Murris-Espin, Jean-Christophe Navellou, Saad Nseir, Walid Oulehri, Thomas Perpoint, Gilles Pialoux, Benoît Pilmis, Vincent Piriou, Lionel Piroth, Valérie Pourcher, Jean-Pierre Quenot, François Raffi, Jean Reignier, Matthieu Revest, Jean-Christophe Richard, Béatrice Riu-Poulenc, Céline Robert, Pierre-Alexandre Roger, Claire Roger, Elisabeth Rouveix-Nordon, Yvon Ruch, Nadia Saidani, Naomi Sayre, Eric Senneville, Albert Sotto, Francois Stefan, Charles Tacquard, Nicolas Terzi, Julien Textoris, Guillaume Thiery, Jean-François Timsit, Violaine Tolsma, Jean-Marie Turmel, Florent Valour, Florent Wallet, Guilhem Wattecamps, Yoann Zerbib, Marc Berna, Jean Reuter, Sandra Braz, Joao-Miguel Ferreira Ribeiro, José-Artur Paiva, Roberto Roncon-Albuquerque, Alexandre Gaymard, Bruno Lina, Sarah Tubiana, Sandrine Couffin-Cadièrgues, Hélène Esperou, Aline Dechanet, Christelle Delmas, Claire Fougerou, Noémie Mercier, Marion Noret, Juliette Saillard, Priyanka Velou, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Internal Medicine, Hospices Civils de Lyon (HCL), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université libre de Bruxelles (ULB), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Imperial College London, Unité de Glycobiologie Structurale et Fonctionnelle - UMR 8576 (UGSF), Université de Lille-Centre National de la Recherche Scientifique (CNRS), ANRS - Maladies infectieuses émergentes (ANRS - MIE), Institut National de la Santé et de la Recherche Médicale (INSERM), Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S_1144 / U1144)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Centre Hospitalier de Luxembourg [Luxembourg] (CHL), Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU), Universidade do Porto = University of Porto, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), ARN régulateurs bactériens et médecine (BRM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Modeling & analysis for medical imaging and Diagnosis (MYRIAD), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), European Union Commission, French Ministry of Health, Domaine d'intérêt majeur One Health Île-de-France, REACTing, Fonds Erasme-COVID-Université Libre de Bruxelles, Belgian Health Care Knowledge Centre, Austrian Group Medical Tumor, European Regional Development Fund, Portugal Ministry of Health, Portugal Agency for Clinical Research and Biomedical Innovation., Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, and UCL - (SLuc) Service de médecine interne générale
Subjects: Male, medicine.medical_specialty, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Population, 030204 cardiovascular system & hematology, Antiviral Agents, law.invention, 03 medical and health sciences, Extracorporeal Membrane Oxygenation, 0302 clinical medicine, Randomized controlled trial, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, law, Internal medicine, Humans, Medicine, media_common.cataloged_instance, 030212 general & internal medicine, European union, education, Contraindication, ComputingMilieux_MISCELLANEOUS, Aged, media_common, Mechanical ventilation, education.field_of_study, Alanine, business.industry, COVID-19, Standard of Care, Odds ratio, Articles, Middle Aged, Respiration, Artificial, Adenosine Monophosphate, COVID-19 Drug Treatment, 3. Good health, Europe, Hospitalization, Oxygen, Clinical trial, Infectious Diseases, Clinical research, Female, business
Abstract: Summary Background The antiviral efficacy of remdesivir against SARS-CoV-2 is still controversial. We aimed to evaluate the clinical efficacy of remdesivir plus standard of care compared with standard of care alone in patients admitted to hospital with COVID-19, with indication of oxygen or ventilator support. Methods DisCoVeRy was a phase 3, open-label, adaptive, multicentre, randomised, controlled trial conducted in 48 sites in Europe (France, Belgium, Austria, Portugal, Luxembourg). Adult patients (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and illness of any duration were eligible if they had clinical evidence of hypoxaemic pneumonia, or required oxygen supplementation. Exclusion criteria included elevated liver enzymes, severe chronic kidney disease, any contraindication to one of the studied treatments or their use in the 29 days before random assignment, or use of ribavirin, as well as pregnancy or breastfeeding. Participants were randomly assigned (1:1:1:1:1) to receive standard of care alone or in combination with remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, or hydroxychloroquine. Randomisation used computer-generated blocks of various sizes; it was stratified on severity of disease at inclusion and on European administrative region. Remdesivir was administered as 200 mg intravenous infusion on day 1, followed by once daily, 1-h infusions of 100 mg up to 9 days, for a total duration of 10 days. It could be stopped after 5 days if the participant was discharged. The primary outcome was the clinical status at day 15 measured by the WHO seven-point ordinal scale, assessed in the intention-to-treat population. Safety was assessed in the modified intention-to-treat population and was one of the secondary outcomes. This trial is registered with the European Clinical Trials Database, EudraCT2020-000936-23, and ClinicalTrials.gov, NCT04315948. Findings Between March 22, 2020, and Jan 21, 2021, 857 participants were enrolled and randomly assigned to remdesivir plus standard of care (n=429) or standard of care only (n=428). 15 participants were excluded from analysis in the remdesivir group, and ten in the control group. At day 15, the distribution of the WHO ordinal scale was: (1) not hospitalised, no limitations on activities (61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control group); (2) not hospitalised, limitation on activities (129 [31%] vs 132 [32%]); (3) hospitalised, not requiring supplemental oxygen (50 [12%] vs 29 [7%]); (4) hospitalised, requiring supplemental oxygen (76 [18%] vs 67 [16%]); (5) hospitalised, on non-invasive ventilation or high flow oxygen devices (15 [4%] vs 14 [3%]); (6) hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (62 [15%] vs 79 [19%]); (7) death (21 [5%] vs 24 [6%]). The difference between treatment groups was not significant (odds ratio 0·98 [95% CI 0·77–1·25]; p=0·85). There was no significant difference in the occurrence of serious adverse events between treatment groups (remdesivir, 135 [33%] of 406 vs control, 130 [31%] of 418; p=0·48). Three deaths (acute respiratory distress syndrome, bacterial infection, and hepatorenal syndrome) were considered related to remdesivir by the investigators, but only one by the sponsor's safety team (hepatorenal syndrome). Interpretation No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19, were symptomatic for more than 7 days, and required oxygen support. Funding European Union Commission, French Ministry of Health, Domaine d'interet majeur One Health Ile-de-France, REACTing, Fonds Erasme-COVID-Universite Libre de Bruxelles, Belgian Health Care Knowledge Centre, Austrian Group Medical Tumor, European Regional Development Fund, Portugal Ministry of Health, Portugal Agency for Clinical Research and Biomedical Innovation. Translation For the French translation of the abstract see Supplementary Materials section.
Published: 2021
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3. Apport de la génomique dans la médecine de demain, applications cliniques et enjeux

Author: Lionel Perrier, Guillaume Grenet, Bruno Laviolle, Florence Gaillard-Bigot, Pascal Bilbault, Olivier Perche, Hélène Espérou, Jean-François Guérin, Julia Morere, Julien Thevenon, Caroline Guillot, Élodie Bégué, François Gueyffier, Damien Sanlaville, Pierre-Henry Longeray, Nathalie Varoqueaux, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Faculté de Médecine Laennec, Université de Lyon, Lyon, France., Ligue Nationale Contre le Cancer - Paris, Ligue Nationale Contre le Cancer (LNCC), The Lymphoma Academic Research Organisation [Lyon] (LYSARC), Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital de la Timone [CHU - APHM] (TIMONE), Hypoxie : Physiopathologie Respiratoire et Cardiovasculaire (HP2 ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Hospices Civils de Lyon, Departement de Neurologie (HCL), Pfizer Oncology, Fédération française des diabétiques, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Groupe d'Analyse et de Théorie Economique Lyon - Saint-Etienne (GATE Lyon Saint-Étienne), École normale supérieure de Lyon (ENS de Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS), Génétique des Anomalies du Développement (GAD), Université de Bourgogne (UB)-IFR100 - Structure fédérative de recherche Santé-STIC, Centre hospitalier universitaire de Grenoble (CHU de Grenoble), CHU Grenoble, Roche SAS, Neuilly-sur-Seine, France, Laboratoire Roche SAS, AstraZeneca, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Ligue Nationnale Contre le Cancer, Hypoxie et physiopathologies cardiovasculaire et respiratoire, Groupe d'analyse et de théorie économique (GATE Lyon Saint-Étienne), Centre National de la Recherche Scientifique (CNRS)-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université Lumière - Lyon 2 (UL2)-École normale supérieure - Lyon (ENS Lyon), École normale supérieure - Lyon (ENS Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), and Dao, Taï
Subjects: Thérapeutique, [QFIN]Quantitative Finance [q-fin], [SDV]Life Sciences [q-bio], Questions éthiques, Médecine personnalisée, 030226 pharmacology & pharmacy, [QFIN] Quantitative Finance [q-fin], Séquençage du génome entier, [SDV] Life Sciences [q-bio], 03 medical and health sciences, 0302 clinical medicine, Pronostic, Pharmacology (medical), Diagnostic
Abstract: International audience; Le séquençage du génome est aujourd’hui accessible à la population mais il n’existe que peu de preuves de son utilité comme outil diagnostique, thérapeutique et pronostique. En France, le plan France médecine génomique 2025 a été lancé en 2015 avec pour objectif d’intégrer les analyses génomiques dans la pratique clinique pour des indications validées et de développer une filière nationale de la médecine génomique incluant des partenariats industriels. Une réflexion sur les applications scientifiques et les enjeux opérationnels et sociétaux est nécessaire afin de formuler des recommandations pour permettre de mieux associer la génomique et la médecine de demain. Dans la perspective d’une médecine factuelle personnalisée, il convient de promouvoir des études avec un niveau d’exigence méthodologique approprié et d’approfondir la définition du niveau de preuve. Les nombreux enjeux opérationnels nécessitent de mettre en place des organisations et des moyens afin de fluidifier le circuit de rendu des résultats ainsi que des adaptations réglementaires sur les statuts des professions impliquées, la gestion des données générées et le consentement des patients. En parallèle des actions de formation en génétique à destination des professionnels de santé et des actions de sensibilisation sur les tests génétiques vis-à-vis du grand public doivent être envisagées. Les enjeux éthiques doivent également être pris en compte, notamment sur la participation du patient aux décisions le concernant en fonction de ses attentes et en intégrant la notion d’incertitude dans l’information délivrée. Les effets sociologiques sur le vécu et les attentes des patients et de la population générale vis-à-vis de la médecine génomique doivent également être évalués pour améliorer l’information, la prévention et l’accompagnement des personnes. Enfin, des études médicoéconomiques doivent être conduites pour éclairer les décideurs sur le caractère coût-efficace du séquençage complet du génome pour la santé des populations.
Published: 2019
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4. A French cohort for assessing COVID-19 vaccine responses in specific populations

Author: Benoit Barrou, David-Axel Laplaud, Odile Launay, Stéphanie Nguyen, Jean-Daniel Lelièvre, Jean-Yves Blay, Benjamin Terrier, Martine Laville, Anne Thiebaut, Jacques Morel, Xavier de Lamballerie, Béatrice Parfait, Bruno Laviolle, Jean-François Viallard, Linda Wittkop, François Vrtovsnik, Jean-Philippe Spano, Paul Loubet, Maryvonne Hourmant, Marie Lachâtre, Eric Tartour, Virulence bactérienne et maladies infectieuses (VBMI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), CHU Bordeaux [Bordeaux], Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Léon Bérard [Lyon], Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Association Francaise d'Etudes et de Recherches sur l'Obesite, Partenaires INRAE, Hospices Civils de Lyon (HCL), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique Henri Mondor (CIC Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre d'Immunologie et des Maladies Infectieuses (CIMI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre Hospitalier Universitaire [Grenoble] (CHU), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Unité des Virus Emergents (UVE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), ANRS00001S, Agence Nationale de Recherches sur le Sida et les Hépatites Virales, Service d'Urologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), HAL-SU, Gestionnaire, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Immunologie et de Maladies Infectieuses (CIMI), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), French-Clinical Research Infrastructure Network - F-CRIN [Paris] (Cardiovascular & Renal Clinical Trialists - CRCT ), Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Université Bordeaux Segalen - Bordeaux 2, CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, CIC Cochin Pasteur (CIC 1417), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP)-Groupe hospitalier Broca-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Institut National de la Santé et de la Recherche Médicale (INSERM), Vaccine Research Institute (VRI), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hôpital Henri Mondor, Université de Montpellier (UM), Hôpital Haut-Lévêque [CHU Bordeaux], Université de Bordeaux (UB), Université de Paris (UP), Institut de Recherche pour le Développement (IRD), Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille), F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Virulence Bactérienne et Infections Chroniques (VBIC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche en Transplantation et Immunologie - Center for Research in Transplantation and Translational Immunology (U1064 Inserm - CR2TI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Grenoble, Université Paris Diderot - Paris 7 (UPD7), Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Subjects: Adult, medicine.medical_specialty, 2019-20 coronavirus outbreak, COVID-19 Vaccines, Adolescent, Coronavirus disease 2019 (COVID-19), Epidemiology, [SDV]Life Sciences [q-bio], Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MEDLINE, Antibodies, Viral, General Biochemistry, Genetics and Molecular Biology, Cohort Studies, Immunocompromised Host, Young Adult, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, 030212 general & internal medicine, Young adult, ComputingMilieux_MISCELLANEOUS, Aged, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, SARS-CoV-2, business.industry, COVID-19, General Medicine, Middle Aged, Antibodies, Neutralizing, Virology, 3. Good health, Viral infection, 030220 oncology & carcinogenesis, Cohort, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, France, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Cohort study
Abstract: International audience; No abstract available
Published: 2021
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5. Sex disparities in COVID-19 outcomes of inpatients with diabetes: insights from the CORONADO study

Author: L Bordier, Pierre Fontaine, Sandrine Lablanche, Abdallah Al-Salameh, Sarra Smati, Amandine Galioot, Adèle Lasbleiz, Olivier Bourron, Matthieu Wargny, Sandrine Coudol, Béatrice Guyomarch, Dominique Seret-Bégué, Sara Barraud, Eric Renard, Céline Gonfroy-Leymarie, Anna Flaus-Furmaniuk, Sybil Charrière, Bertrand Cariou, Emmanuel Cosson, Philippe Thuillier, Franck Mauvais-Jarvis, Jean-François Gautier, Bruno Vergès, Edith Bigot, Bruno Guerci, Bruno Fève, Matthieu Pichelin, Jean-Daniel Lalau, Louis Potier, Muriel Bourgeon, Samy Hadjadj, Gaëtan Prévost, Etienne Larger, Marion Munch, Nicolas Chevalier, Yves Reznik, Sophie Borot, Paul Sibilia, Pierre Gourdy, Bruno Laviolle, Coralie Amadou, Michel Marre, Blandine Tramunt, Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de recherche de l'institut du thorax (ITX-lab), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Amiens-Picardie, Périnatalité et Risques Toxiques - UMR INERIS_I 1 (PERITOX), Institut National de l'Environnement Industriel et des Risques (INERIS)-Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Centre Hospitalier Sud Francilien, Centre Hospitalier Universitaire de Reims (CHU Reims), Centre de Recherche en Sciences et Technologies de l'Information et de la Communication - EA 3804 (CRESTIC), Université de Reims Champagne-Ardenne (URCA), Hôpital d'Instruction des Armées Begin, Service de Santé des Armées, Service de Diabétologie - Endocrinologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), AP-HP - Hôpital Antoine Béclère [Clamart], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Universitaire de Nice (CHU Nice), Hôpital Jean Verdier [AP-HP], Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Saint-Antoine [AP-HP], Centre hospitalier Félix-Guyon [Saint-Denis, La Réunion], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Claude Huriez [Lille], CHU Lille, CHU Bordeaux [Bordeaux], Centre Hospitalier René Dubos [Pontoise], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CHU Grenoble, AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance Publique - Hôpitaux de Marseille (APHM), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Hôpital Ambroise Paré [AP-HP], CHU Strasbourg, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Différenciation et communication neuronale et neuroendocrine (DC2N), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'endocrinologie, diabétologie et maladies métaboliques [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier de Gonesse, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service de Diabétologie et Endocrinologie, Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Tulane University, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Diabétologie [CHU Pitié-Salpétrière], École pratique des hautes études (EPHE), CRHU Nancy, Jonchère, Laurent, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de l'Environnement Industriel et des Risques, CH Evry-Corbeil, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), and CHU Toulouse [Toulouse]
Subjects: Male, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, Severity of Illness Index, law.invention, 0302 clinical medicine, Endocrinology, Risk Factors, law, Hospital Mortality, Aged, 80 and over, [SDV.MHEP.EM] Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, Sex Characteristics, COPD, Incidence, Incidence (epidemiology), General Medicine, Middle Aged, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, Prognosis, Intensive care unit, 3. Good health, Hospitalization, [SDV] Life Sciences [q-bio], Intensive Care Units, Population study, Female, France, Sex characteristics, medicine.medical_specialty, Diabetes Complications, 03 medical and health sciences, Internal medicine, Diabetes mellitus, Severity of illness, Diabetes Mellitus, medicine, Humans, Aged, Retrospective Studies, Inpatients, SARS-CoV-2, business.industry, COVID-19, Retrospective cohort study, medicine.disease, Respiration, Artificial, business, 030217 neurology & neurosurgery
Abstract: Objective Male sex is one of the determinants of severe coronavirus diseas-e-2019 (COVID-19). We aimed to characterize sex differences in severe outcomes in adults with diabetes hospitalized for COVID-19. Methods We performed a sex-stratified analysis of clinical and biological features and outcomes (i.e. invasive mechanical ventilation (IMV), death, intensive care unit (ICU) admission and home discharge at day 7 (D7) or day 28 (D28)) in 2380 patients with diabetes hospitalized for COVID-19 and included in the nationwide CORONADO observational study (NCT04324736). Results The study population was predominantly male (63.5%). After multiple adjustments, female sex was negatively associated with the primary outcome (IMV and/or death, OR: 0.66 (0.49–0.88)), death (OR: 0.49 (0.30–0.79)) and ICU admission (OR: 0.57 (0.43–0.77)) at D7 but only with ICU admission (OR: 0.58 (0.43–0.77)) at D28. Older age and a history of microvascular complications were predictors of death at D28 in both sexes, while chronic obstructive pulmonary disease (COPD) was predictive of death in women only. At admission, C-reactive protein (CRP), aspartate amino transferase (AST) and estimated glomerular filtration rate (eGFR), according to the CKD-EPI formula predicted death in both sexes. Lymphocytopenia was an independent predictor of death in women only, while thrombocytopenia and elevated plasma glucose concentration were predictors of death in men only. Conclusions In patients with diabetes admitted for COVID-19, female sex was associated with lower incidence of early severe outcomes, but did not influence the overall in-hospital mortality, suggesting that diabetes mitigates the female protection from COVID-19 severity. Sex-associated biological determinants may be useful to optimize COVID-19 prevention and management in women and men.
Published: 2021
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6. Validation and reproducibility of a short food frequency questionnaire for cardiovascular prevention

Author: François Paillard, Guillaume Mahé, Bruno Laviolle, Ophélie Flageul, C. Dourmap, Vincent Auffret, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), No funding, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, Cardiovascular risk factors, 030204 cardiovascular system & hematology, Alimentation, Validity, 03 medical and health sciences, 0302 clinical medicine, Cardiovascular prevention, Surveys and Questionnaires, Vegetables, Medicine, Dietary Questionnaire, Humans, 030212 general & internal medicine, Maladies cardiovasculaires, Validité, Reproducibility, Health professionals, business.industry, Questionnaire, Healthy subjects, Food frequency questionnaire, Reproducibility of Results, General Medicine, 3. Good health, Diet, Cardiovascular diseases, Fruit, Physical therapy, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Cardiology and Cardiovascular Medicine, business, Reproductibilité
Abstract: International audience; BACKGROUND: Diet strongly influences cardiovascular risk. Dietary evaluation is a major issue in cardiovascular prevention, but few simple tools are available. Our team previously validated a short food frequency questionnaire; a new version of this questionnaire (Cardiovascular Dietary Questionnaire 2 [CDQ-2]) is easier to complete and more reliable. AIMS: To validate CDQ-2 in comparison with the original version, and to test its reproducibility. METHODS: CDQ-2 has 17 closed-ended questions; it provides a global dietary score that is a combination of specific scores for saturated, monounsaturated and omega-3 fatty acids, and fruit and vegetables. CDQ-2 was validated against the original version in two groups, who completed both questionnaires: 99 patients with cardiovascular risk factors and 50 healthy subjects. Reproducibility was assessed with 27 health professionals who completed the questionnaire twice, with a 1-month interval. RESULTS: The correlation coefficients of the scores between the two questionnaires ranged from 0.65 (monounsaturated fatty acids) to 0.93 (fruit and vegetables) (all P
Published: 2021
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7. Balanced Opioid-free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Remifentanil for Major or Intermediate Noncardiac Surgery

Author: J. Nadaud, Sylvain Lecoeur, Antoine Roquilly, Elisabeth Dubout, M. Mazerolles, Bruno Laviolle, Emmanuel Futier, Hélène Beloeil, Gilles Lebuffe, Julien Bila, Thomas Godet, Alexandre Gerbaud, Antoine Becret, Nicolas Coullier, Stéphanie Sigaut, Matthias Garot, Pierre-Marie Choinier, Karim Asehnoune, Maxime Esvan, Julie Fayon, Sebastien Oger, Gerald Chanques, Philippe Cuvillon, F. Atallah, CHU Pontchaillou [Rennes], CHU Lille, Génétique, Reproduction et Développement (GReD), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Anesthésie Réanimation [Rennes], Unité de réanimation médicale [CHU de Carémeau, Nîmes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Clinique Francheville [Périgueux], Centre hospitalier régional Metz-Thionville (CHR Metz-Thionville), Hôpital Yves LE FOLL [Saint-Brieuc], Pôle Anesthésie Réanimation [CHU de Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service de Gastroentérologie [Hôpital Beaujon], Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service d'anesthésie et réanimation chirurgicale [Nantes], Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Balanced Anesthesia, business.industry, [SDV]Life Sciences [q-bio], Remifentanil, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, 3. Good health, 03 medical and health sciences, Desflurane, 0302 clinical medicine, Anesthesiology and Pain Medicine, Nefopam, MESH: Female, Humans, Male, Middle Aged, Pain, Postoperative / drug therapy, Prospective Studies, 030202 anesthesiology, Anesthesia, Medicine, Ketamine, 030212 general & internal medicine, MESH: Remifentanil / therapeutic use, Single-Blind Method, Treatment Outcome, medicine.symptom, Dexmedetomidine, business, Propofol, Postoperative nausea and vomiting, medicine.drug, MESH: Analgesics, Non-Narcotic / therapeutic use, Analgesics, Opioid / therapeutic use, Balanced Anesthesia / methods, Dexmedetomidine / therapeutic use
Abstract: BackgroundIt is speculated that opioid-free anesthesia may provide adequate pain control while reducing postoperative opioid consumption. However, there is currently no evidence to support the speculation. The authors hypothesized that opioid-free balanced anesthetic with dexmedetomidine reduces postoperative opioid-related adverse events compared with balanced anesthetic with remifentanil.MethodsPatients were randomized to receive a standard balanced anesthetic with either intraoperative remifentanil plus morphine (remifentanil group) or dexmedetomidine (opioid-free group). All patients received intraoperative propofol, desflurane, dexamethasone, lidocaine infusion, ketamine infusion, neuromuscular blockade, and postoperative lidocaine infusion, paracetamol, nefopam, and patient-controlled morphine. The primary outcome was a composite of postoperative opioid-related adverse events (hypoxemia, ileus, or cognitive dysfunction) within the first 48 h after extubation. The main secondary outcomes were episodes of postoperative pain, opioid consumption, and postoperative nausea and vomiting.ResultsThe study was stopped prematurely because of five cases of severe bradycardia in the dexmedetomidine group. The primary composite outcome occurred in 122 of 156 (78%) dexmedetomidine group patients compared with 105 of 156 (67%) in the remifentanil group (relative risk, 1.16; 95% CI, 1.01 to 1.33; P = 0.031). Hypoxemia occurred 110 of 152 (72%) of dexmedetomidine group and 94 of 155 (61%) of remifentanil group patients (relative risk, 1.19; 95% CI, 1.02 to 1.40; P = 0.030). There were no differences in ileus or cognitive dysfunction. Cumulative 0 to 48 h postoperative morphine consumption (11 mg [5 to 21] versus 6 mg [0 to 17]) and postoperative nausea and vomiting (58 of 157 [37%] versus 37 of 157 [24%]; relative risk, 0.64; 95% CI, 0.45 to 0.90) were both less in the dexmedetomidine group, whereas measures of analgesia were similar in both groups. Dexmedetomidine patients had more delayed extubation and prolonged postanesthesia care unit stay.ConclusionsThis trial refuted the hypothesis that balanced opioid-free anesthesia with dexmedetomidine, compared with remifentanil, would result in fewer postoperative opioid-related adverse events. Conversely, it did result in a greater incidence of serious adverse events, especially hypoxemia and bradycardia.Editor’s PerspectiveWhat We Already Know about This TopicWhat This Article Tells Us That Is New
Published: 2021
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8. Mega randomized clinical trials: a definitive solution or a double-edged sword?

Author: Florian Lemaitre, Bruno Laviolle, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université d'Angers (UA), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Jonchère, Laurent
Subjects: medicine.medical_specialty, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, Mega, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, SWORD, Intensive care medicine, Pandemics, Point of View, ComputingMilieux_MISCELLANEOUS, Randomized Controlled Trials as Topic, Pharmacology, SARS-CoV-2, business.industry, General Medicine, COVID-19 Drug Treatment, 3. Good health, [SDV] Life Sciences [q-bio], Research Design, Sample Size, business
Abstract: International audience
Published: 2021
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9. Vulvar and vaginal melanomas: A retrospective study spanning 19 years from a tertiary center

Author: Thierry Lesimple, Ludivine Dion, Chloé Rousseau, Vincent Lavoué, Susie Brousse, Bruno Laviolle, Jean Lévêque, Krystel Nyangoh Timoh, Marine Joste, and Astrid Reilhac
Subjects: Female circumcision, Adult, medicine.medical_specialty, Multivariate analysis, Time Factors, Vaginal Neoplasms, Gastroenterology, Disease-Free Survival, Vulva, Tertiary Care Centers, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, Humans, First Recurrence, Melanoma, Aged, Retrospective Studies, Aged, 80 and over, 030219 obstetrics & reproductive medicine, Mucous Membrane, Vulvar Neoplasms, business.industry, Mucosal melanoma, Obstetrics and Gynecology, Retrospective cohort study, Middle Aged, medicine.disease, Prognosis, Increased risk, medicine.anatomical_structure, Reproductive Medicine, 030220 oncology & carcinogenesis, Vagina, Lymph Node Excision, Female, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract: Introduction Mucosal melanomas (MM) of the female genital tract are rare a. We aimed to study the prognostic factors of vulvar and vaginal locations of MM. Material and method A multicenter, retrospective cohort study conducted between 01/01/2000 and 01/06/2019. Result Of the 33 patients included 25 (75.8 %) had vulvar (VuM) and eight (24.2 %) vaginal melanomas (VaM). VaMs were deeper: median Breslow index: 17.5 mm [3.5−22] versus 4.3 mm [0.35−18] (p = 0.013). Average follow-up was 24.0 ± 59.8 months. Twenty-six patients (78.8 %) experienced recurrence. Disease-free survival was 52.9 % at 1 year (64.7 % for VuM and 14.3 % for VaM) and 8.4 % at 3 years (11 % for VuM and 0% for VaM) (p = 0.002). Median time to the first recurrence was 9.01 months [CI95 %: 2.07–56.71]. VaM recurred earlier than VuM (3.12 months [CI95 %: 2.07–12.49] versus 17.72 [CI95 %: 3.58–56.71], p = 0.011). VaM had a higher risk of recurrence (HR = 5.64 [CI95 %: 2.01–15.82], p = 0.001) in multivariate analysis. Overall survival was 88.5 % at 1 year (100 % for VuM and 50 % for VaM), and 59.4 % at 3 years (69.3 % for VuM and 25 % for VaM). Women with VaM died earlier: median specific death occurrence of 8.76 months [CI95 %: 6.54–24.72] versus 39.61 [CI95 %: 21.89–209.21], p = 0.013 (HR = 5.08 [CI95 %: 1.39–18.60], p = 0.014). A lesion size ≥3 cm was associated with an increased risk of mortality (HR = 8.45 [CI95 %: 1.60–44.52], p = 0.012). In multivariate analysis, vaginal location remained an independent and predictive variable of a higher risk of specific death (HR = 8.56 [CI95 %: 1.95–37.64], p = 0.005). Conclusion A vaginal location of MM is associated with a poorer prognosis than a vulvar location.
Published: 2020

10. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial

Author: Andrew J Pollard, Odile Launay, Jean-Daniel Lelievre, Christine Lacabaratz, Sophie Grande, Neil Goldstein, Cynthia Robinson, Auguste Gaddah, Viki Bockstal, Aurelie Wiedemann, Maarten Leyssen, Kerstin Luhn, Laura Richert, Christine Bétard, Malick M Gibani, Elizabeth A Clutterbuck, Matthew D Snape, Yves Levy, Macaya Douoguih, Rodolphe Thiebaut, Christopher McShane, Benoit Callendret, Stephanie Dincq, Camille Ferrault, Siew Pin Chai, Maire Paule Gyselen, Marleen van Looveren, Sylvia van Ballert, Tinne de Cnodder, Len Roza, Chiara Forcheh, Kate Stevens, Carmela Mastrandrea, Sanne de Ridder, Rachana Gundluru, Nathalie Swales, Vanessa Errijegers, Wouter Willems, Veronika Roorda, Nicola Orzabal, Magdalena Assenberg, Karine Vialatte, Frédéric Remblier, Elodie Porcar, Anton Ottavi, Eugénie Destandau, Christine Schwimmer, Laetitia Moinot, Cédrick Wallet, Florence Allais, Hélène Savel, Naouel Nedjaai, Anaïs Maugard, Nehza Lenzi, Pierre Loulergue, Mathilde Bahuaud, Fabrice Lainé, Bruno Laviolle, Nolwenn Boissel, Elise Thébault, David Vallée, Jean-François Nicolas, Sophie Gilbert, Karima Dahel, Karen Sagorny, Frédéric Lucht, Stéphane Paul, Alice Haccourt Chanavat, Florent Charra, Catherine Mutter, Monique Lambour, Caroline Muller, Anne Hutt-Clauss, Olivia Aranda, Louis Bernard, Valérie Gissot, Marie-Charlotte Hallouin-Bernard, Alain Goudeau, Steve Suzzoni, Eva Auostin, Lysiane Brick, Jose-Luis Lopez-Zaragoza, Giovanna Melic, Murial Carvalho, Chrystel Chesnel, Hakim Hocini, Aurélie Wiedemann, Laurent Hanot, Véronique Rieux, Adeep Puri, Temitope Adeloye, Malcolm Boyce, Jeremy Dennison, Inge Loewenstein, Omar Sahgal, Frans van den Berg, Wendy Calvert, Mary Faldon, Bruce McClain, Marie-Lousie Newell, Geert Molenberghs, Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 0301 basic medicine, Adult, Male, medicine.medical_specialty, Modified vaccinia Ankara, Adolescent, [SDV]Life Sciences [q-bio], Placebo, Antibodies, Viral, Injections, Intramuscular, Cohort Studies, Placebos, 03 medical and health sciences, Viral Proteins, Young Adult, 0302 clinical medicine, Immunogenicity, Vaccine, Internal medicine, Medicine, Humans, 030212 general & internal medicine, Ebola Vaccines, Adverse effect, ComputingMilieux_MISCELLANEOUS, Immunization Schedule, Aged, Glycoproteins, Vaccines, Synthetic, Ebola vaccine, business.industry, Hemorrhagic Fever, Ebola, Middle Aged, Ebolavirus, United Kingdom, 3. Good health, Vaccination, Regimen, 030104 developmental biology, Infectious Diseases, Tolerability, Cohort, Female, France, business
Abstract: Summary Background To address the unmet medical need for an effective prophylactic vaccine against Ebola virus we assessed the safety and immunogenicity of three different two-dose heterologous vaccination regimens with a replication-deficient adenovirus type 26 vector-based vaccine (Ad26.ZEBOV), expressing Zaire Ebola virus glycoprotein, and a non-replicating, recombinant, modified vaccinia Ankara (MVA) vector-based vaccine, encoding glycoproteins from Zaire Ebola virus, Sudan virus, and Marburg virus, and nucleoprotein from the Tai Forest virus. Methods This randomised, observer-blind, placebo-controlled, phase 2 trial was done at seven hospitals in France and two research centres in the UK. Healthy adults (aged 18–65 years) with no history of Ebola vaccination were enrolled into four cohorts. Participants in cohorts I–III were randomly assigned (1:1:1) using computer-generated randomisation codes into three parallel groups (randomisation for cohorts II and III was stratified by country and age), in which participants were to receive an intramuscular injection of Ad26.ZEBOV on day 1, followed by intramuscular injection of MVA-BN-Filo at either 28 days (28-day interval group), 56 days (56-day interval group), or 84 days (84-day interval group) after the first vaccine. Within these three groups, participants in cohort II (14:1) and cohort III (10:3) were further randomly assigned to receive either Ad26.ZEBOV or placebo on day 1, followed by either MVA-BN-Filo or placebo on days 28, 56, or 84. Participants in cohort IV were randomly assigned (5:1) to receive one dose of either Ad26.ZEBOV or placebo on day 1 for vector shedding assessments. For cohorts II and III, study site personnel, sponsor personnel, and participants were masked to vaccine allocation until all participants in these cohorts had completed the post-MVA-BN-Filo vaccination visit at 6 months or had discontinued the trial, whereas cohort I was open-label. For cohort IV, study site personnel and participants were masked to vaccine allocation until all participants in this cohort had completed the post-vaccination visit at 28 days or had discontinued the trial. The primary outcome, analysed in all participants who had received at least one dose of vaccine or placebo (full analysis set), was the safety and tolerability of the three vaccination regimens, as assessed by participant-reported solicited local and systemic adverse events within 7 days of receiving both vaccines, unsolicited adverse events within 42 days of receiving the MVA-BN-Filo vaccine, and serious adverse events over 365 days of follow-up. The secondary outcome was humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies at 21 days after receiving the MVA-BN-Filo vaccine. The secondary outcome was assessed in the per-protocol analysis set. This study is registered at ClinicalTrials.gov , NCT02416453 , and EudraCT, 2015-000596-27. Findings Between June 23, 2015, and April 27, 2016, 423 participants were enrolled: 408 in cohorts I–III were randomly assigned to the 28-day interval group (123 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo), and 15 participants in cohort IV were assigned to receive Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo (n=2). 421 (99·5%) participants received at least one dose of vaccine or placebo. The trial was temporarily suspended after two serious neurological adverse events were reported, one of which was considered as possibly related to vaccination, and per-protocol vaccination was disrupted for some participants. Vaccinations were generally well tolerated. Mild or moderate local adverse events (mostly pain) were reported after 206 (62%) of 332 Ad26.ZEBOV vaccinations, 136 (58%) of 236 MVA-BN-Filo vaccinations, and 11 (15%) of 72 placebo injections. Systemic adverse events were reported after 255 (77%) Ad26.ZEBOV vaccinations, 116 (49%) MVA-BN-Filo vaccinations, and 33 (46%) placebo injections, and included mostly mild or moderate fatigue, headache, or myalgia. Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections. At 21 days after receiving the MVA-BN-Filo vaccine, geometric mean concentrations of Ebola virus glycoprotein-binding antibodies were 4627 ELISA units (EU)/mL (95% CI 3649–5867) in the 28-day interval group, 10 131 EU/mL (8554–11 999) in the 56-day interval group, and 11 312 mL (9072–14106) in the 84-day interval group, with antibody concentrations persisting at 1149–1205 EU/mL up to day 365. Interpretation The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo was safe, well tolerated, and immunogenic, with humoral and cellular immune responses persisting for 1 year after vaccination. Taken together, these data support the intended prophylactic indication for the vaccine regimen. Funding Innovative Medicines Initiative and Janssen Vaccines & Prevention BV. Translation For the French translation of the abstract see Supplementary Materials section.
Published: 2020
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11. Blood glucose levels and COVID-19. Reply to Sardu C, D’Onofrio N, Balestrieri ML et al [letter] and Lepper PM, Bals R, Jüni P et al [letter]

Author: Amélie Ducet-Boiffard, Muriel Bourgeon-Ghittori, Claude Chaumeil, Louis Potier, Florence Baudoux, Jean François Gautier, Jean-Pierre Riveline, Coralie Amadou, Emmanuel Cosson, Emmanuel Disse, Michael Joubert, Gaëtan Prévost, Pierre Gourdy, Olivier Bourron, Véronique Kerlan, Blandine Tramunt, Sophie Borot, Charles Thivolet, Abdallah Al-Salameh, Matthieu Wargny, Bruno Laviolle, René Robert, Lucien Marchand, Gwénaëlle Arnault, Ariane Sultan, Laurent Meyer, Sandrine Coudol, David Boutoille, Matthieu Pichelin, Pierre Jean Saulnier, Patrice Darmon, Bernard Bauduceau, Bénédicte Gaborit, Ronan Roussel, Bertrand Cariou, Ingrid Allix, Camille Vatier, Samy Hadjadj, Jean François Thébaut, Unité de recherche de l'institut du thorax (ITX-lab), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Hôpital Guillaume-et-René-Laennec [Saint-Herblain], Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Amiens-Picardie, Université de Picardie Jules Verne (UPJV), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Sud Francilien, Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA), Hôpital Claude Huriez [Lille], CHU Lille, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), AP-HP - Hôpital Antoine Béclère [Clamart], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Service des maladies infectieuses et tropicales [CHU Nantes], Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Fédération française des diabétiques, Hôpital Avicenne [AP-HP], Centre de Recherche en Nutrition Humaine - Ile de France (CRNH - IDF), Unité de Recherche en Epidémiologie Nutritionnelle (UREN), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Sorbonne Paris Nord, Service d'endocrinologie, diabète, maladies métaboliques [Hôpital de la Conception - APHM], Aix Marseille Université (AMU), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Nord [CHU - APHM], Service Endocrinologie - Diabétologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier Saint Joseph - Saint Luc [Lyon], CHU Strasbourg, Service d'endocrinologie, diabétologie et nutrition [CHU Bichat], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), CHU Rouen, Normandie Université (NU), Hôpital Lariboisière-Fernand-Widal [APHP], CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Saint-Antoine [AP-HP], Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CORONADO, Société Francophone du Diabète, CORONADO, Fondation francophone Recherche Diabète, CORONADO, Fonds dotation du CHU de Nantes, unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), CH Evry-Corbeil, Service de Diabétologie [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université de Paris (UP), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Sorbonne Paris Nord, Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-CHU Saint-Eloi-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Toulouse [Toulouse], Service d'Endocrinologie, diabétologie et endocrinologie de la reproduction [CHU Saint-Antoine], Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Gestionnaire, Hal Sorbonne Université, Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de diabétologie [CHU Pitié-Salpétrière], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP]
Subjects: 2019-20 coronavirus outbreak, biology, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], COVID-19, 030209 endocrinology & metabolism, Human physiology, medicine.disease, biology.organism_classification, Virology, [SDV] Life Sciences [q-bio], 03 medical and health sciences, Pneumonia, 0302 clinical medicine, Pandemic, Internal Medicine, Medicine, 030212 general & internal medicine, business, Coronavirus Infections, Betacoronavirus, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2020
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12. Phenotypic characteristics and prognosis of inpatients with COVID-19 and diabetes: the CORONADO study

Author: Amélie Ducet-Boiffard, Muriel Bourgeon-Ghittori, Claude Chaumeil, Pierre Jean Saulnier, Sandrine Coudol, Bertrand Cariou, Camille Vatier, Jean François Gautier, David Boutoille, Charles Thivolet, Abdallah Al-Salameh, Pierre Gourdy, Sophie Borot, Michael Joubert, Samy Hadjadj, Bruno Laviolle, Matthieu Wargny, Ingrid Allix, Ariane Sultan, Florence Baudoux, Gaëtan Prévost, René Robert, Coralie Amadou, Laurent Meyer, Jean-Pierre Riveline, Matthieu Pichelin, Patrice Darmon, Blandine Tramunt, Bernard Bauduceau, Jean François Thébaut, Gwénaëlle Arnault, Olivier Bourron, Lucien Marchand, Bénédicte Gaborit, Ronan Roussel, Emmanuel Cosson, Emmanuel Disse, Véronique Kerlan, Louis Potier, Centre hospitalier universitaire de Nantes (CHU Nantes), unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), CHU Amiens-Picardie, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Sud Francilien, CH Evry-Corbeil, Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital d'Instruction des Armées Begin, Service de Santé des Armées, Service de Diabétologie - Endocrinologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), AP-HP - Hôpital Antoine Béclère [Clamart], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Diabétologie [CHU Pitié-Salpétrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service des maladies infectieuses et tropicales [CHU Nantes], Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Fédération française des diabétiques, Université Sorbonne Paris Cité (USPC), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Service d'endocrinologie, nutrition et maladies métaboliques [Hôpital Nord - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Les Hôpitaux Universitaires de Strasbourg (HUS), Service d'endocrinologie, diabétologie, nutrition, Différenciation et communication neuronale et neuroendocrine (DC2N), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université de Paris (UP), Service des urgences [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), CORONADO Initiative Emergency grant, Air Liquide, CORONADO Initiative Emergency Grant, Fondation Francophone pour la Recherche sur le Diabète, CORONADO Initiative Emergency Grant, Sociéte Francophone du Diabète, Unité de recherche de l'institut du thorax (ITX-lab), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'endocrinologie, diabétologie et maladies métaboliques [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Service des urgences [CHU Poitiers], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Picardie Jules Verne (UPJV), Service de diabétologie - endocrinologie, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Hôpital Antoine Béclère, Service de diabétologie [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Unité de Recherche en Epidémiologie Nutritionnelle (UREN), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Sorbonne Paris Nord, Centre de Recherche en Nutrition Humaine - Ile de France (CRNH - IDF), Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'endocrinologie, diabète, maladies métaboliques [Hôpital de la Conception - APHM], Aix Marseille Université (AMU), Centre recherche en CardioVasculaire et Nutrition (C2VN), Aix Marseille Université (AMU)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), École pratique des hautes études (EPHE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université de Paris (UP), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre Hospitalier Universitaire de Toulouse, Jonchère, Laurent, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, and Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL)
Subjects: medicine.medical_specialty, HbA1c, medicine.medical_treatment, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, Logistic regression, Article, 03 medical and health sciences, BMI, 0302 clinical medicine, Mechanical ventilation, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Internal medicine, Diabetes mellitus, medicine, Internal Medicine, 030212 general & internal medicine, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, [SDV.MHEP.EM] Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, Univariate analysis, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, business.industry, Tracheal intubation, Diabetes, COVID-19, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, medicine.disease, Comorbidity, 3. Good health, Death, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Hypertension, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Observational study, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract: Aims/hypothesis Coronavirus disease-2019 (COVID-19) is a life-threatening infection caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus. Diabetes has rapidly emerged as a major comorbidity for COVID-19 severity. However, the phenotypic characteristics of diabetes in COVID-19 patients are unknown. Methods We conducted a nationwide multicentre observational study in people with diabetes hospitalised for COVID-19 in 53 French centres in the period 10–31 March 2020. The primary outcome combined tracheal intubation for mechanical ventilation and/or death within 7 days of admission. Age- and sex-adjusted multivariable logistic regressions were performed to assess the prognostic value of clinical and biological features with the endpoint. ORs are reported for a 1 SD increase after standardisation. Results The current analysis focused on 1317 participants: 64.9% men, mean age 69.8 ± 13.0 years, median BMI 28.4 (25th–75th percentile: 25.0–32.7) kg/m2; with a predominance of type 2 diabetes (88.5%). Microvascular and macrovascular diabetic complications were found in 46.8% and 40.8% of cases, respectively. The primary outcome was encountered in 29.0% (95% CI 26.6, 31.5) of participants, while 10.6% (9.0, 12.4) died and 18.0% (16.0, 20.2) were discharged on day 7. In univariate analysis, characteristics prior to admission significantly associated with the primary outcome were sex, BMI and previous treatment with renin–angiotensin–aldosterone system (RAAS) blockers, but not age, type of diabetes, HbA1c, diabetic complications or glucose-lowering therapies. In multivariable analyses with covariates prior to admission, only BMI remained positively associated with the primary outcome (OR 1.28 [1.10, 1.47]). On admission, dyspnoea (OR 2.10 [1.31, 3.35]), as well as lymphocyte count (OR 0.67 [0.50, 0.88]), C-reactive protein (OR 1.93 [1.43, 2.59]) and AST (OR 2.23 [1.70, 2.93]) levels were independent predictors of the primary outcome. Finally, age (OR 2.48 [1.74, 3.53]), treated obstructive sleep apnoea (OR 2.80 [1.46, 5.38]), and microvascular (OR 2.14 [1.16, 3.94]) and macrovascular complications (OR 2.54 [1.44, 4.50]) were independently associated with the risk of death on day 7. Conclusions/interpretations In people with diabetes hospitalised for COVID-19, BMI, but not long-term glucose control, was positively and independently associated with tracheal intubation and/or death within 7 days. Trial registration clinicaltrials.gov NCT04324736.
Published: 2020
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13. Correction to: Phenotypic characteristics and prognosis of inpatients with COVID-19 and diabetes: the CORONADO study

Author: Coralie Amadou, Michael Joubert, Patrice Darmon, Samy Hadjadj, Amélie Ducet-Boiffard, Gwénaëlle Arnault, Pierre Jean Saulnier, Blandine Tramunt, Bertrand Cariou, Charles Thivolet, Abdallah Al-Salameh, Ingrid Allix, Emmanuel Cosson, Emmanuel Disse, Bruno Laviolle, Florence Baudoux, Matthieu Wargny, Véronique Kerlan, Muriel Bourgeon-Ghittori, Ariane Sultan, Bénédicte Gaborit, Olivier Bourron, Ronan Roussel, René Robert, Laurent Meyer, Camille Vatier, Sophie Borot, David Boutoille, Claude Chaumeil, Louis Potier, Jean François Gautier, Gaëtan Prévost, Jean-Pierre Riveline, Lucien Marchand, Bernard Bauduceau, Matthieu Pichelin, Jean François Thébaut, Pierre Gourdy, Sandrine Coudol, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Service d'endocrinologie, nutrition et maladies métaboliques [Hôpital Nord - APHM], Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), and Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM]
Subjects: 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), [SDV]Life Sciences [q-bio], Endocrinology, Diabetes and Metabolism, MEDLINE, Correction, 030209 endocrinology & metabolism, Human physiology, medicine.disease, Phenotype, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Diabetes mellitus, Internal Medicine, Medicine, business, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2020
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14. Hypnosis and communication reduce pain and anxiety in peripheral intravenous cannulation Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE), a multicentre randomised trial

Author: Séverine Delahaye-Larralde, Hélène Beloeil, Franck Bernard, Sébastien Barthes, Cassiopée Pouliquen, Pierre Hugot, Fabienne Roelants, Emilie Rolland, Christine Watremez, Pierre Fillatre, Natacha Boulon, Patricia Branchu, Charlotte Donal, Cécile Gauvrit, Simon Schonne, Chloé Rousseau, Isabelle Leroyer, Catherine Copin-Eliat, Alain Renault, Hervé Musellec, Bruno Laviolle, Nicolas Fusco, Julie Rullier, Mustapha Ahmin, Nicolas Guillou, Thomas Yven, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Université Catholique de Louvain = Catholic University of Louvain (UCL), CHU Pontchaillou [Rennes], Teaching hospital of Rennes, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Privé Saint-Grégoire [Saint-Gregoire] (CHPSG - Bretagne), Cliniques Universitaires Saint-Luc [Bruxelles], Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) group: Mustapha Ahmin, Sébastien Barthes, Natacha Boulon, Patricia Branchu, Catherine Copin-Eliat, Séverine Delahaye-Larralde, Pierre Fillatre, Charlotte Donal, Pierre Hugot, Cécile Gauvrit, Nicolas Guillou, Isabelle Leroyer, Cassiopée Pouliquen, Alain Renault, Emilie Rolland, Chloé Rousseau, Julie Rullier, Simon Schonne, Thomas Yven, CCSD, Accord Elsevier, UCL - (SLuc) Service d'anesthésiologie, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, and UCL - SSS/IREC/MEDA - Pôle de médecine aiguë
Subjects: Adult, Male, medicine.medical_specialty, Hypnosis, Nocebo, Adolescent, medicine.drug_class, [SDV]Life Sciences [q-bio], Hypnotic, 03 medical and health sciences, Young Adult, 0302 clinical medicine, 030202 anesthesiology, Rating scale, Patient experience, Catheterization, Peripheral, Medicine, Humans, Single-Blind Method, pain, peripheral intravenous cannulation, Aged, Pain Measurement, Aged, 80 and over, business.industry, patient experience, Communication, Pain Perception, anaesthesia, Middle Aged, anxiety, 3. Good health, Peripheral, [SDV] Life Sciences [q-bio], Clinical trial, Anesthesiology and Pain Medicine, Physical therapy, Anxiety, Educational Status, hypnosis, Female, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract: International audience; Background - Clinicians traditionally warn patients of pain before peripheral i.v. cannulation (PIVC). However, using words related to pain or undesirable experiences can result in greater pain and anxiety. The use of positive words can improve pain perception and subjective patient experience. We aimed to compare the effects of three types of communication, including hypnotic communication, on pain, comfort, and anxiety in patients during PIVC. Methods - The Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) trial is a randomised, parallel, single-blind, multicentre study of patients undergoing PIVC on the dorsal face of the hand before surgery. Patients from three hospitals were randomly allocated to one of three groups: PIVC performed with a hypnosis technique (hypnosis group), negative connotation (nocebo group), and neutral connotation (neutral group). The primary outcome measure was the occurrence of pain measured with a 0-10 numerical rating scale just after PIVC. Results - Of the 272 subjects analysed (hypnosis, n=89; nocebo, n=92; neutral, n=91), pain after PIVC was lower in the hypnosis group (mean [standard deviation]; range) (1.5 [1.9]; 0-5) compared with the neutral (3.5 [2.3]; 0-9; P
Published: 2020
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15. DWI-Based Algorithm to Predict Disability in Patients Treated with Thrombectomy for Acute Stroke

Author: Jean-Christophe Ferré, B. Parat, Bruno Laviolle, Hélène Raoult, C. Rousseau, François Eugène, J.Y. Gauvrit, A. Le Bras, M.V. Lassalle, Stephane Vannier, Sarah Evain, Thomas Ronzière, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, Multivariate analysis, [SDV]Life Sciences [q-bio], 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Medicine, Humans, Radiology, Nuclear Medicine and imaging, In patient, Artery occlusion, cardiovascular diseases, Acute stroke, Aged, Retrospective Studies, Thrombectomy, Aged, 80 and over, Receiver operating characteristic, Groin, Interventional, business.industry, Retrospective cohort study, Middle Aged, Prognosis, 3. Good health, Stroke, medicine.anatomical_structure, Diffusion Magnetic Resonance Imaging, Treatment Outcome, ROC Curve, Observational study, Female, Neurology (clinical), business, Algorithm, 030217 neurology & neurosurgery, Algorithms
Abstract: International audience; BACKGROUND AND PURPOSE The reasons for poor clinical outcome after thrombectomy for acute stroke, concerning around half of all patients, are misunderstood. We developed a hierarchic algorithm based on DWI to better identify patients at high risk of disability. MATERIALS AND METHODS Our single-center, retrospective study included consecutive patients with acute ischemic stroke who underwent thrombectomy for large anterior artery occlusion and underwent pretreatment DWI. The primary outcome was the mRS at 3 months after stroke onset. Multivariable regression was used to identify independent clinical and imaging predictors of poor prognosis (mRS > 2) at 3 months, and a hierarchic algorithm predictive of disability was developed. RESULTS A total of 149 patients were analyzed. In decreasing importance, DWI lesion volume of >80 mL, baseline NIHSS score of >14, age older than 75 years, and time from stroke onset to groin puncture of >4 hours were independent predictors of poor prognosis. The predictive hierarchic algorithm developed from the multivariate analysis predicted the risk of disability at 3 months for up to 100% of patients with a high predictive value. The area under the receiver operating characteristic curve was 0.87. CONCLUSIONS The DWI-based hierarchic algorithm we developed is highly predictive of disability at 3 months after thrombectomy and is easy to use in routine practice. © 2020 by American Journal of Neuroradiology.
Published: 2020
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16. Certification ISO 9001 d’un système de management qualité dans un centre d’investigation clinique

Author: Alain Renault, Eric Bellissant, Bruno Laviolle, Claire Fougerou-Leurent, Claire Laforest, and Jimmy Chesnais
Subjects: Engineering, Standardization, business.industry, media_common.quotation_subject, Certification, 030226 pharmacology & pharmacy, Clinical trial, 03 medical and health sciences, Engineering management, 0302 clinical medicine, Quality management system, Clinical investigation, Pharmacology (medical), Quality (business), Good practice, business, media_common
Abstract: Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article.
Published: 2018
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17. Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders: a systematic review with direct and network meta-analyses on nalmefene, naltrexone, acamprosate, baclofen and topiramate

Author: Alexandre Huneau, Clément Palpacuer, Bruno Laviolle, Renan Duprez, Clara Locher, Rémy Boussageon, and Florian Naudet
Subjects: Topiramate, medicine.medical_specialty, business.industry, Alcohol dependence, Medicine (miscellaneous), Alcohol use disorder, medicine.disease, Naltrexone, 3. Good health, law.invention, 03 medical and health sciences, Psychiatry and Mental health, 0302 clinical medicine, Acamprosate, Randomized controlled trial, law, Internal medicine, Meta-analysis, medicine, 030212 general & internal medicine, business, Psychiatry, 030217 neurology & neurosurgery, Nalmefene, medicine.drug
Abstract: Background and aims - Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders (AUDs) is an emerging concept. Our objective was to explore the comparative effectiveness of drugs used in this indication. Design - Systematic review with direct and network meta-analysis of double-blind randomized controlled trials (RCTs) assessing the efficacy of nalmefene, naltrexone, acamprosate, baclofen or topiramate in non-abstinent adults diagnosed with alcohol dependence or AUDs. Two independent reviewers selected published and unpublished studies on Medline, the Cochrane Library, Embase, ClinicalTrials.gov, contacted pharmaceutical companies, the European Medicines Agency and the Food and Drug Administration, and extracted data. Setting - Thirty-two RCTs. Participants - A total of 6036 patients. Measurements - The primary outcome was total alcohol consumption (TAC). Other consumption outcomes and health outcomes were considered as secondary outcomes. Findings - No study provided direct comparisons between drugs. A risk of incomplete outcome data was identified in 26 studies (81%) and risk of selective outcome reporting in 17 (53%). Nalmefene [standardized mean difference (SMD) = -0.19, 95% confidence interval (CI) = -0.29, -0.10; I = 0%], baclofen (SMD = -1.00, 95% CI = -1.80, -0.19; one study) and topiramate (SMD = -0.77, 95% CI = -1.12, -0.42; I = 0%) showed superiority over placebo on TAC. No efficacy was observed for naltrexone or acamprosate. Similar results were observed for other consumption outcomes, except for baclofen (the favourable outcome on TAC was not reproduced). The number of withdrawals for safety reasons increased under nalmefene and naltrexone. No treatment demonstrated any harm reduction (no study was powered to explore health outcomes). Indirect comparisons suggested that topiramate was superior to nalmefene, naltrexone and acamprosate on consumption outcomes, but its safety profile is known to be poor. Conclusions - There is currently no high-grade evidence for pharmacological treatment to control drinking using nalmefene, naltrexone, acamprosate, baclofen or topiramate in patients with alcohol dependence or alcohol use disorder. Some treatments show low to medium efficacy in reducing drinking across a range of studies with a high risk of bias. None demonstrates any benefit on health outcomes.
Published: 2017
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18. From single-arm studies to externally controlled studies. Methodological considerations and guidelines

Author: Xavier Paoletti, Matthieu Roustit, Florence Binlich, Bruno Laviolle, Cécile Fouret, Jehan-Michel Behier, Olivier Delaitre, Silvy Laporte, Houda Miadi-Fargier, Serge Bureau, Catherine Cornu, Nathalie Varoqueaux, Anne d’Andon, Tabassome Simon, Michel Cucherat, Natalie Hoog Labouret, Eric Vicaut, Jérémie Westerloppe, Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Santé Ingénierie Biologie Saint-Etienne (SAINBIOSE), Centre Ingénierie et Santé (CIS-ENSMSE), École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Recherches SERVIER (IRS), CIC CHU Lyon (inserm), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Medtronic SNT, Medtronic, Institut national du cancer [Boulogne] (INCA), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Bayer HealthCare Pharmaceuticals Inc [Whippany], Cancer et génome: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Bristol-Myers Squibb Company, INSERM U1059, SAINBIOSE - Santé, Ingénierie, Biologie, Saint-Etienne (SAINBIOSE-ENSMSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Curie [Paris]-MINES ParisTech - École nationale supérieure des mines de Paris, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Cancer et génôme: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, MINES ParisTech - École nationale supérieure des mines de Paris-Institut Curie-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Sorbonne Paris Nord
Subjects: Non-comparative, Relation (database), Computer science, As is, [SDV]Life Sciences [q-bio], Guidelines as Topic, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Bias, medicine, Humans, Pharmacology (medical), Predicable, Attrition, External control study, Reliability (statistics), Randomized Controlled Trials as Topic, Protocol (science), Clinical Trials as Topic, Control group, Indirect comparison, Reproducibility of Results, Gold standard (test), Formal methods, medicine.disease, 3. Good health, Risk analysis (engineering), Single-arm study, Research Design, Matching-adjusted indirect comparisons
Abstract: International audience; Single-arm studies are sometimes used as pivotal studies but they have methodological limitations which prevent them from obtaining the high level of reliability as for a randomised controlled study which remains the gold standard in the evaluation of new treatments. The objective of this roundtable was to discuss the limitations of these single-arm studies, to analyse available and acceptable solutions in order to propose guidelines for their conduct and assessment. Single-arm studies themselves are intrinsically inappropriate for demonstrating the benefit of a new treatment because it is impossible to infer the benefit from a value obtained under treatment without knowing what it would have been in the absence of the new treatment. The implication is that comparison with other data is necessary. However this comparison has limitations due to (1) the post hoc choice of the reference used for comparison, (2) the confusion bias for which an adjustment approach is imperative and, (3) the other biases, measure and attrition among others. When these limitations are taken into account this should, first and foremost, lead to the conduct of externally controlled trials instead of single-arm trials as is proposed by the latest version of ICH E10. Moreover, the external control must be formalised in the study protocol with a priori selection of both the reference control and the formal method of comparison test in relation to a standard, adjustment on individual data, a synthetic control group or matching-adjusted indirect comparisons (MAIC). Lastly, externally controlled studies must be restricted to situations where randomisation is infeasible. To be acceptable, these studies must be able to guarantee freedom from residual confusion bias, which is only truly acceptable if the observed effect is dramatic and the usual course of the disease is highly predicable.
Published: 2020
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19. Des études mono-bras aux études de comparaison externe. Considérations méthodologiques et recommandations

Author: Florence Binlich, Silvy Laporte, Houda Miadi-Fargier, Jérémie Westerloppe, Jehan-Michel Behier, Olivier Delaitre, Catherine Cornu, Anne d’Andon, Natalie Hoog Labouret, Xavier Paoletti, Eric Vicaut, Nathalie Varoqueaux, Tabassome Simon, Bruno Laviolle, Matthieu Roustit, Michel Cucherat, Cécile Fouret, Serge Bureau, Jonchère, Laurent, Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Service Hospitalo-Universitaire de Pharmacotoxicologie [Lyon], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), INSERM U1059, SAINBIOSE - Santé, Ingénierie, Biologie, Saint-Etienne (SAINBIOSE-ENSMSE), Centre Ingénierie et Santé (CIS-ENSMSE), École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Boehringer Ingelheim France S.A.S., Celgene [Paris La Défense], Cemka-eval [Bourg La Reine], Institut de Recherches Internationales Servier [Suresnes] (IRIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CIC CHU Lyon (inserm), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Medtronic SNT, Medtronic, Institut national du cancer [Boulogne] (INCA), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Bayer HealthCare Pharmaceuticals Inc [Whippany], Cancer et génome: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hypoxie : Physiopathologie Respiratoire et Cardiovasculaire (HP2), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Unité de Recherche Clinique de l’Est Parisien [CHU Saint-Antoine] (URC-EST), Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO)-CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AstraZeneca [Courbevoie], Unité de Recherche Clinique (Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [APHP]), Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Bristol-Myers Squibb [Rueil-Malmaison], Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Recherches SERVIER (IRS), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Cancer et génôme: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, MINES ParisTech - École nationale supérieure des mines de Paris-Institut Curie-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Sorbonne Paris Nord, Bristol-Myers Squibb Company, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Ingénierie et Santé (CIS-ENSMSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT), Institut Curie [Paris]-MINES ParisTech - École nationale supérieure des mines de Paris, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Santé Ingénierie Biologie Saint-Etienne (SAINBIOSE), Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière] (CIC Paris-Est), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)
Subjects: [SDV] Life Sciences [q-bio], 03 medical and health sciences, Étude de contrôle externe, 0302 clinical medicine, Non-comparative, Comparaisons indirectes ajustées, Groupe contrôle, [SDV]Life Sciences [q-bio], Études mono-bras, Comparaison indirecte, Pharmacology (medical), 030226 pharmacology & pharmacy, ComputingMilieux_MISCELLANEOUS
Abstract: National audience; Les études mono-bras sont parfois utilisées comme études pivots mais elles présentent des limites méthodologiques qui ne leur permettent pas d’obtenir un niveau de fiabilité élevé comme peut l’être celui de l’essai contrôlé randomisé qui reste le standard de l’évaluation des nouveaux traitements. L’objectif de cette table ronde était de discuter des limites de ces études, d’analyser les solutions disponibles et acceptables afin de proposer des recommandations pour leur réalisation et leur évaluation. Les études mono-bras proprement dites sont intrinsèquement inadaptées pour démontrer le bénéfice d’un nouveau traitement car il est impossible de déduire ce bénéfice à partir d’une valeur sous traitement sans connaître ce qu’elle aurait été en l’absence du nouveau traitement. Une comparaison avec d’autres données est alors implicite. Cependant, cette comparaison est limitée par (1) le choix post-hoc de la référence de la comparaison, (2) le biais de confusion qui nécessite impérativement une approche d’ajustement, et (3) les autres biais, de mesure et d’attrition entres autres. La prise en considération de ces limites devrait conduire, avant tout, à la réalisation d’essais à contrôle externe (« externally controlled trial ») à la place des essais mono-bras comme le propose la dernière version d’ICH E10. Par ailleurs, la comparaison externe doit être formalisée dans le protocole de l’étude avec un choix a priori de la référence de comparaison ainsi que la méthode de comparaison formelle : test par rapport à une norme, ajustement avec des données individuelles, groupe contrôle synthétique ou « matching-adjusted indirect comparisons (MAIC) ». Finalement, l’essai de comparaison externe doit être réservé aux situations où la randomisation est irréalisable. Pour être acceptable, ces études doivent pouvoir donner la garantie d’absence de biais de confusion résiduelle, ce qui n’est vraiment recevable que si l’effet observé est extrêmement important et l’évolution de la maladie fortement prévisible.
Published: 2020
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20. Targeting T-cell senescence and cytokine storm with rapamycin to prevent severe progression in COVID-19

Author: Olivier Meilhac, Guillaume Mahé, Loukman Omarjee, Anne Janin, Bruno Laviolle, Frédérique Perrot, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Pontchaillou [Rennes], Marqueurs cardiovasculaires en situation de stress (MASCOT (UMR_S_942 / U942)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)-Université Sorbonne Paris Nord, Diabète athérothrombose et thérapies Réunion Océan Indien (DéTROI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de La Réunion (UR), Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), CHU de Rennes – Corect, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, and Université de La Réunion (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: T-Lymphocytes, [SDV]Life Sciences [q-bio], TIGIT, T-cell Immunoreceptor with Ig and ITIM (Immunoreceptor Tyrosine-based Inhibition Motif) domains, 0302 clinical medicine, Immunology and Allergy, IL, Interleukin, Molecular Targeted Therapy, TLR, Toll Like Receptor, ComputingMilieux_MISCELLANEOUS, CTLA-4, Cytotoxic T Lymphocyte Associated protein 4, Regulation of gene expression, G-CSF, Granulocyte Colony Stimulating factor, 0303 health sciences, CD, Cluster of Differentiation, MIP-1α, Macrophage Inflammatory Protein 1 alpha, 3. Good health, PD-1, Programmed cell Death 1, Cytokine release syndrome, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Disease Progression, COVID-19, Corona-Virus-Disease-2019, Cytokines, Coronavirus Infections, Cytokine Release Syndrome, TNFα, Tumor Necrosis Factor alpha, medicine.drug, Senescence, Coronavirus disease 2019 (COVID-19), T cell, Pneumonia, Viral, Immunology, Article, NF-κB, Nuclear Factor-kappa B, Betacoronavirus, 03 medical and health sciences, Immunity, MCP-1, Monocyte Chemoattractant Protein 1, Tim-3, T-cell immunoglobulin mucin-3, medicine, Humans, Immunologic Factors, NLRP3, Nucleotide-binding oligomerization domain (NOD)-Like Receptor family, Pyrin domain containing 3, Pandemics, 030304 developmental biology, Sirolimus, SARS-CoV-2, business.industry, COVID-19, medicine.disease, Immunity, Innate, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2, Gene Expression Regulation, IP-10, Interferon gamma-induced Protein 10, Cancer research, mTOR, mammalian Target Of Rapamycin, Cytokine storm, business, IFN-γ, Interferon gamma, ROS, Reactive Oxygen Species
Abstract: International audience
Published: 2020
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21. Predictive factors associated with involved margins in breast cancer treated with neoadjuvant chemotherapy followed by breast-conserving therapy

Author: Patrick Tas, Eugenie Beraud, Krystel Nyangoh Timoh, Ludivine Dion, Vincent Lavoué, Christophe Perrin, Jean Levêque, Aude Tavenard, F. Foucher, Elise Davoine, Bruno Laviolle, CHU Pontchaillou [Rennes], CRLCC Eugène Marquis (CRLCC), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CCSD, Accord Elsevier, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, medicine.medical_specialty, Neoplasm, Residual, medicine.medical_treatment, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Mastectomy, Segmental, Neoadjuvant chemotherapy, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, [SDV.CAN] Life Sciences [q-bio]/Cancer, Risk Factors, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, ComputingMilieux_MISCELLANEOUS, Aged, Retrospective Studies, Breast-Conserving, Chemotherapy, Invasive carcinoma, Tumor size, business.industry, Carcinoma, Ductal, Breast, Ultrasound, Outcome measures, Margins of Excision, Obstetrics and Gynecology, Histology, Retrospective cohort study, Middle Aged, Prognosis, medicine.disease, Neoadjuvant Therapy, 3. Good health, Treatment Outcome, Reproductive Medicine, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Surgery, Radiology, business
Abstract: Introduction : This study sought to identify predictive factors of involved surgical margins in breast-conserving surgery (BCS) after neoadjuvant chemotherapy (NAC) to help guide the surgical procedure. Materials and Methods : Retrospective study of patients who had BCS after NAC between January 2008 and December 2013. Outcome measure: tumor-involved margin, defined by tumor cells on ink for invasive cancer and tumor-free margin Results : Ninety-seven patients were included. The median age of patients was 46 years old [28–71]. The initial average tumor size was 47.8 mm [+/- 18.6]. Twelve patients (12.4%) had involved tumor margins on final histology after BCS and NAC. According to the multivariate model including only preoperative variables of positive margins, initial ultrasound tumor size ≤ 27 mm (p = 0.045) and low SBR grade (p = 0.009) were independently associated with tumor-involved margins. According to the multivariate model including pre- and postoperative variables of positive margins, ductal carcinomain situ was also independently associated with tumor-involved margins (p = 0.021). Conclusion : Initial ultrasound tumor size ≤ 27 mm and low SBR grade were independently associated with tumor-involved margins. These preoperative data were very helpful to guide the surgical procedure in breast cancer.
Published: 2019
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22. Serum CD95L Level Correlates with Tumor Immune Infiltration and Is a Positive Prognostic Marker for Advanced High-Grade Serous Ovarian Cancer

Author: Jean Levêque, Julien Corné, Matthieu Le Gallo, Patrick Legembre, Alain Fautrel, Marie Le Boulch, Aurélie Cauchois, Sébastien Henno, Bruno Laviolle, Vincent Lavoué, Estelle Le Pabic, Clotilde Poupon, Thibault De La Motte Rouge, Nathalie Rioux-Leclercq, Véronique Catros, Centre Eugène Marquis (CRLCC), Chemistry, Oncogenesis, Stress and Signaling (COSS), Institut National de la Santé et de la Recherche Médicale (INSERM)-CRLCC Eugène Marquis (CRLCC)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), CHU Pontchaillou [Rennes], Institut de Génétique et Développement de Rennes (IGDR), Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes 1 (UR1), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CRLCC Eugène Marquis (CRLCC), 2017, Ligue Contre le Cancer, 2016, Fondation ARC pour la Recherche sur le Cancer, 2014, La Vannetaise, PLASTICO 2017, Canceropole Grand Ouest, 2017, INCa PLBIO, 2018, ANR PRCE, Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Centre National de la Recherche Scientifique (CNRS)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 0301 basic medicine, Cancer Research, Fas Ligand Protein, medicine.medical_treatment, CD3, [SDV]Life Sciences [q-bio], tumor immune infiltration, [SDV.CAN]Life Sciences [q-bio]/Cancer, Apoptosis, T-Lymphocytes, Regulatory, 03 medical and health sciences, 0302 clinical medicine, Immune system, Lymphocytes, Tumor-Infiltrating, Cell Movement, medicine, Biomarkers, Tumor, Cytotoxic T cell, Humans, Molecular Biology, Cell Proliferation, Neoplasm Staging, CD20, Ovarian Neoplasms, B-Lymphocytes, biology, business.industry, FOXP3, Forkhead Transcription Factors, Immunotherapy, soluble CD95 ligand, Middle Aged, Prognosis, High grade serous ovarian cancer, 3. Good health, Cystadenocarcinoma, Serous, Granzyme B, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Cancer research, biology.protein, Female, business, CD8
Abstract: Soluble CD95L (s-CD95L) is a chemoattractant for certain lymphocyte subpopulations. We examined whether this ligand is a prognostic marker for high-grade serous ovarian cancer (HGSOC) and whether it is associated with accumulation of immune cells in the tumor. Serum s-CD95L levels in 51 patients with advanced ovarian cancer were tested by ELISA. IHC staining of CD3, CD4, CD8, CD20, CD163, CD31, FoxP3, CCR6, IL-17, Granzyme B, PD-L1, and membrane CD95L was used to assess tumor-infiltrating immune cells. Although the intensity of CD3, CD8, CD4, CD20, and CD163 in tumor tissues remained constant regardless of membrane CD95L expression, tumors in patients with HGSOC with s-CD95L levels ≥516 pg/mL showed increased infiltration by CD3+ T cells (P = 0.001), comprising both cytotoxic CD8+ (P = 0.01) and CD4+ (P = 0.0062) cells including FoxP3+ regulatory T cells (P = 0.0044). Also, the number of tumor-infiltrating CD20+ B cells (P = 0.0094) increased in these patients. Multivariate analyses revealed that low s-CD95L concentrations [6,000 CD3+ cells (HR, 0.34; 95% CI, 0.15–0.79) was a good prognostic factor. Thus, low levels of s-CD95L ( Implications: Serum s-CD95L is correlated with a number of tumor-infiltrating immune cells in HGSOC and could be used as a noninvasive marker of tumor immune infiltration to select patients referred for immunotherapy trials that evaluate checkpoint inhibitor treatment.
Published: 2019
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23. Targeted screening of COPD in primary care: Feasibility and effectiveness

Author: J Fouchard, Bruno Laviolle, Jeanine Pommier, C Laforest, G. Brinchault, B Yourish, François-Xavier Schweyer, S Oumari, Emmanuel Allory, E. Andres, Laure Fiquet, Anthony Chapron, Stéphane Jouneau, A Banâtre, A Veislinger, F Pelé, C Fougerou, Stéphanie Guillot, V Turmel, Centre de Recherches sur l'Action Politique en Europe (ARENES), Université de Rennes (UR)-Institut d'Études Politiques [IEP] - Rennes-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Centre National de la Recherche Scientifique (CNRS), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Centre Maurice Halbwachs (CMH), École des hautes études en sciences sociales (EHESS)-Centre National de la Recherche Scientifique (CNRS)-Département de Sciences sociales ENS-PSL, École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL), École des Hautes Études en Santé Publique [EHESP] (EHESP), EA Management des Organisations de Santé (EA MOS), École des Hautes Études en Santé Publique [EHESP] (EHESP)-PRES Sorbonne Paris Cité, Département des sciences humaines et sociales (SHS), and CCSD, Accord Elsevier
Subjects: Pulmonary and Respiratory Medicine, Gynecology, medicine.medical_specialty, Public health, business.industry, Spirométrie, [SDV]Life Sciences [q-bio], Santé publique, Étude multicentrique, 3. Good health, Dépistage (systématique), [SDV] Life Sciences [q-bio], 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Soins primaires, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Médecine générale, Bronchopneumopathie chronique obstructive, Medicine, COPD, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, 030212 general & internal medicine, business, Mass screening
Abstract: IntroductionLa bronchopneumopathie chronique obstructive (BPCO) est une pathologie frequente mais sous diagnostiquee en soins primaires. L’objectif etait d’etudier la faisabilite d’un essai controle randomise en medecine generale visant a detecter plus precocement de nouveaux cas de BPCO.MethodesEtude interventionnelle multicentrique controlee randomisee en cluster comparant selon un plan factoriel 2 × 2, deux strategies de detection : hetero-questionnaire GOLD-HAS et mise en place d’une coordination du parcours du patient pour faciliter l’acces a une spirometrie. L’etude pilote s’est deroulee en 2017. Etaient inclus tout patient de 40 a 80 ans, non-BPCO connus, consultant leur medecin generaliste un jour donne.Resultats176 patients ont ete inclus en 1,5 jours. Le nombre de spirometries prescrites etait de 0 dans le bras controle, 13 (29,5 %) dans le bras « questionnaire », 22 (50 %) dans le bras coordination, et 32 (72,7 %) avec l’association des deux strategies. Deux BPCO stade 2 et treize autres pathologies respiratoires ont ete diagnostiquees.ConclusionsCette etude confirme la faisabilite du protocole en soins primaires en termes de rapidite d’inclusions et d’acceptabilite. Une phase d’extension prevoyant d’inclure 3200 patients permettra d’evaluer l’interet diagnostique des deux strategies testees en medecine generale.
Published: 2019
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24. The contribution of genomics in the medicine of tomorrow, clinical applications and issues

Author: Florence Gaillard-Bigot, Patrice Denèfle, Nathalie Varoqueaux, Damien Sanlaville, Jean-François Guérin, Lionel Perrier, Olivier Perche, Julia Morere, Caroline Guillot, Pascal Bilbault, François Gueyffier, Pierre-Henry Longeray, Guillaume Grenet, Élodie Bégué, Bruno Laviolle, Julien Thevenon, Hélène Espérou, Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Généthon, Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Ligue Nationale Contre le Cancer - Paris, Ligue Nationale Contre le Cancer (LNCC), Les Hôpitaux Universitaires de Strasbourg (HUS), Agence de la biomédecine [Saint-Denis la Plaine], Hypoxie : Physiopathologie Respiratoire et Cardiovasculaire (HP2 ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Hospices Civils de Lyon (HCL), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Fédération française des diabétiques, Centre Hospitalier Régional d'Orléans (CHRO), Centre Léon Bérard [Lyon], Groupe d'Analyse et de Théorie Economique Lyon - Saint-Etienne (GATE Lyon Saint-Étienne), École normale supérieure de Lyon (ENS de Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS), Service de Cytogénétique (HFME), Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Centre de génétique - Centre de référence des maladies rares, anomalies du développement et syndromes malformatifs (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Roche SAS, Neuilly-sur-Seine, France, Laboratoire Roche SAS, The advent of a new paradigm induced by the massive deployment of high-throughput sequencing raises economic and organisational issues. The evaluation of the production cost of genome sequences shows a notable change in the production costs of a gene panel targeted by next-generation sequencing (NGS) according to indications, enrichment techniques, retained sequencing, or the number of patients per run. In France, for example, the cost per patient (from the receipt of samples to the return of results to prescribers) varies from one to three depending on the laboratories [17]. What about the cost of genome sequencing? One can assume that production costs will largely depend on the organisational model chosen and its ability to integrate multiple technical constraints (prescription portals, automated extraction systems, production platform, IT infrastructure, data analysis, rendering of results, interoperability with patient records, etc.).The medico-economic assessment of the genome-wide sequencing strategy is essential to inform policy makers on the cost-effectiveness (or not) of one or more innovative health strategies compared to the reference strategy (s). These assessments are planned in the pilot projects of the France genomics 2025 plan. This approach has well-known benefits such as the absence (most often) of selection bias. In contrast, the time horizon of the economic evaluation is usually limited to the follow-up period of the trial and differential cost-result ratio (DCRR) is not always expressed in cost per year of life gained in good health. These can also emanate from modelling. The review of the literature published by Schwarze et al. on genome sequencing reports a very limited number (N = 8) of publications including a complete medico-economic assessment (i.e. that integrates economic considerations and clinical efficacy) [18]. Furthermore, the heterogeneity of the efficacy criteria does not favour comparisons between studies. Only one of them expresses the DCRR in cost per year of life gained in good health [19]., Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Roche, Université de Lyon, Ligue Nationnale Contre le Cancer, Hypoxie et physiopathologies cardiovasculaire et respiratoire, Institut National de la Santé et de la Recherche Médicale (INSERM), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'analyse et de théorie économique (GATE Lyon Saint-Étienne), Centre National de la Recherche Scientifique (CNRS)-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université Lumière - Lyon 2 (UL2)-École normale supérieure - Lyon (ENS Lyon), Dao, Taï, and École normale supérieure - Lyon (ENS Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL)
Subjects: Big Data, Process (engineering), [SDV]Life Sciences [q-bio], Commodity, Population, education, Genomics, Population health, Therapeutics, Social issues, 030226 pharmacology & pharmacy, [SHS]Humanities and Social Sciences, Translational Research, Biomedical, 03 medical and health sciences, 0302 clinical medicine, Diagnosis, Humans, Genomic medicine, Pharmacology (medical), Precision Medicine, education.field_of_study, Evidence-Based Medicine, business.industry, Ethical issues, Prognosis, Personalized medicine, 3. Good health, [SDV] Life Sciences [q-bio], Whole genome sequencing, Engineering ethics, France, [SHS] Humanities and Social Sciences, business
Abstract: International audience; Fifteen years after the completion of first human genome sequencing, the technique is almost a commodity but there is still little evidence of its usefulness as a diagnostic, prognostic or therapeutic tool. In France, the France genomics plan 2025 was launched in 2015 with the goal of integrating genomic tests into clinical practice and developing a National genomics network including industrial partnerships. Reflection on scientific applications and operational or societal issues is needed to make recommendations to help better associate Genomics and the medicine of tomorrow. In the perspective of personalized Evidence-based Medicine, studies with an appropriate methodological level to improve the definition of evidence should be promoted. The many operational challenges require the implementation of organisations and means to streamline the process of results reporting, and regulatory adaptations concerning the status of professions involved, the management of data generated, and the consent of patients. In parallel, genetic training for healthcare professionals and raising awareness on genetic tests for the public should be considered. The ethical stake should also be taken into account, especially on the participation of the patient in decisions concerning them and integrating the notion of uncertainty into the information given. The sociological effects on the experience and expectations of patients and the general population towards genomic medicine should also be evaluated to improve information, prevention and support for people. Finally, medico-economic studies must be conducted to inform policy-makers on the cost-effectiveness of complete genome sequencing for population health.
Published: 2019
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25. Population Pharmacokinetic-Pharmacodynamic Model of Oral Fludrocortisone and Intravenous Hydrocortisone in Healthy Volunteers

Author: Jean-Claude Alvarez, Bruno Laviolle, Emmanuelle Comets, Noureddine Hamitouche, Eric Bellissant, Mégane Ribot, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Infection et inflammation (2I), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Male, medicine.medical_specialty, Hydrocortisone, [SDV]Life Sciences [q-bio], Fludrocortisone, Potassium, Population, Anti-Inflammatory Agents, Administration, Oral, Pharmaceutical Science, chemistry.chemical_element, Pharmacology, 030226 pharmacology & pharmacy, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Pharmacokinetics, Internal medicine, pharmacodynamics, medicine, Humans, education, IC50, education.field_of_study, Cross-Over Studies, Chemistry, Modeling, Models, Theoretical, Crossover study, Healthy Volunteers, 3. Good health, Endocrinology, Pharmacodynamics, pharmacokinetics, 030217 neurology & neurosurgery, medicine.drug
Abstract: International audience; This study aimed at describing the pharmacokinetics and the concentration-effect relationships of fludrocortisone and hydrocortisone on urinary sodium/potassium excretion in healthy volunteers. This was a placebo-controlled, randomized, double blind, crossover study, of oral fludrocortisone and intravenous hydrocortisone, given alone or in combination, in 12 healthy male volunteers. Nonlinear mixed-effects modeling was used to describe the pharmacokinetics and pharmacokinetic-pharmacodynamic relationships on urinary sodium/potassium ratio for each drug. A one-compartment model was used to describe fludrocortisone and hydrocortisone pharmacokinetics. Mean plasma half-life was 1.40 h (95%CI [0.80;2.10]) for fludrocortisone and 2.10 h (95%CI [1.78;2.40]) for hydrocortisone. Clearance was 40.8 L/h (95%CI [33.6;48]) for fludrocortisone and 30 L/h (95%CI [25.3;34.7]) for hydrocortisone. An indirect response model was used to describe effects on urinary sodium/potassium ratio. Fludrocortisone plasma concentrations showed a wider inter-individual dispersion than hydrocortisone plasma concentrations. Urinary sodium/potassium ratio variability was also higher with fludrocortisone as compared to hydrocortisone. The plasma concentration of drug producing 50% of maximal inhibition of urinary sodium/potassium (IC50) was about 200 times lower for fludrocortisone (0.08 μg/L, 95%CI [0.035;0.125]) than for hydrocortisone (16.7 μg/L, 95%CI [10.5;22.9]). Simulations showed that a 4-time per day administration regimen allow to achieve steady fludrocortisone plasma concentrations with stable decrease in urinary sodium/potassium ratio after the second administration of fludrocortisone. Fludrocortisone and hydrocortisone have short and similar plasma elimination half-lives in healthy subjects. Fludrocortisone plasma concentrations and effect on urinary sodium/potassium ratio had a higher inter-individual variability as compared to hydrocortisone. The administration regimen of fludrocortisone should be reconsidered.
Published: 2017
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26. Pharmacokinetics of oral fludrocortisone in septic shock

Author: Eric Bellissant, Angelo Polito, Bruno Laviolle, Jean-Claude Alvarez, Andrea Polito, Noureddine Hamitouche, Djillali Annane, and Mégane Ribot
Subjects: Pharmacology, Volume of distribution, medicine.medical_specialty, Septic shock, business.industry, Fludrocortisone, Area under the curve, 030204 cardiovascular system & hematology, medicine.disease, Gastroenterology, 3. Good health, Sepsis, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, Hypovolemia, Anesthesia, Internal medicine, Shock (circulatory), medicine, Pharmacology (medical), 030212 general & internal medicine, medicine.symptom, business, medicine.drug
Abstract: Aim: The combination of hydrocortisone and fludrocortisone improved outcomes in septic shock. However, the specific role of fludrocortisone remains controversial and its pharmacokinetics (PK) has never been investigated in septic shock. This study aimed at characterizing the PK of fludrocortisone in septic shock. Methods: This was a single-centre ancillary PK study of a large multinational trial of crystalloids versus colloids for acute hypovolemia in intensive care unit (ICU) patients. In 21 adults with septic shock, fludrocortisone plasma concentrations were measured by liquid chromatography-mass spectrometry tandem analysis, before and repeatedly until 18 h after an oral dose of 50 μg. PK parameters were estimated using a nonlinear mixed-effects modelling. Results: Undetectable plasma concentrations were observed in 7 out of 21 patients. In the remaining 14 patients, plasma fludrocortisone concentrations were best described by a one-compartmental model with first-order absorption, a lag time (Tlag ) before the absorption phase, and first-order elimination. Severity of illness, as quantified by Simplified Acute Physiology Score II, significantly increased Tlag and apparent clearance. There was a large inter-individual variability in PK parameters. The population estimates of PK parameters (inter-individual variability) were: Tlag 0.65 h (98%), apparent clearance 40 l h-1 (49%) and apparent volume of distribution 78 l (75%). Plasma half-life was estimated at 1.35 h (95% CI, 0.84-2.03) and area under the curve of plasma concentrations was estimated at 1.25 μg h l-1 (95% CI, 1.09-1.46). Conclusions: A single oral dose of fludrocortisone yielded undetectable plasma concentrations in one-third of adults with septic shock. Fludrocortisone PK showed a short plasma elimination half-life and a large inter-individual variability.
Published: 2016
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27. Joint Model of Iron and Hepcidin During the Menstrual Cycle in Healthy Women

Author: Aline Moignet, Martine Ropert, Audrey Lavenu, Fabrice Lainé, Valérie Gissot, Karine Lacut, Emmanuelle Comets, Caroline Jezequel, Bruno Laviolle, Adeline Angeli, Sylvie Sacher-Huvelin, Jonchère, Laurent, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), Université de Rennes (UR), Centre de référence des surcharges en fer rares d'origine génétique, Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), CIC - Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC, Institut des Maladies de l'Appareil Digestif, University Hospital, Service des Maladies de l'Appareil Digestif [CHU Rennes], Service de Pharmacologie [Rennes], Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), PHRC inter-régional 2012 (PHRC/12-02), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Faculté de médecine, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Service des Maladies de l'Appareil Digestif, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC), Université de Rennes - Faculté de Médecine (UR Médecine), and Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM)
Subjects: Adult, turnover model, 0301 basic medicine, medicine.medical_specialty, Iron, [SDV]Life Sciences [q-bio], media_common.quotation_subject, Hepcidin, Pharmaceutical Science, Models, Biological, menstrual cycle, Menstruation, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Anti-Infective Agents, Hepcidins, Blood loss, iron regulation, hemic and lymphatic diseases, Internal medicine, medicine, Humans, Young adult, Menstrual cycle, media_common, Morning, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, medicine.diagnostic_test, biology, business.industry, Healthy Volunteers, 3. Good health, [SDV] Life Sciences [q-bio], Ferritin, 030104 developmental biology, Endocrinology, 030220 oncology & carcinogenesis, Serum iron, biology.protein, Female, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Research Article
Abstract: International audience; Hepcidin regulates serum iron levels, and its dosage is used in differential diagnostic of iron-related pathologies. We used the data collected in the HEPMEN (named after HEPcidin during MENses) study to investigate the joint dynamics of serum hepcidin and iron during the menstrual cycle in healthy women. Ninety menstruating women were recruited after a screening visit. Six fasting blood samples for determination of iron-status variables were taken in the morning throughout the cycle, starting on the second day of the period. Non-linear mixed effect models were used to describe the evolution of iron and hepcidin. Demographic and medical covariates were tested for their effect on model parameters. Parameter estimation was performed using the SAEM algorithm implemented in the Monolix software. A general pattern was observed for both hepcidin and iron, consisting of an initial decrease during menstruation, followed by a rebound and stabilising during the second half of the cycle. We developed a joint model including a menstruation-induced decrease of both molecules at the beginning of the menses and a rebound effect after menses. Iron stimulated the release of hepcidin. Several covariates, including contraception, amount of blood loss and ferritin, were found to influence the parameters. The joint model of iron and hepcidin was able to describe the fluctuations induced by blood loss from menstruation in healthy non-menopausal women and the subsequent regulation. The HEPMEN study showed fluctuations of iron-status variables during the menstrual cycle, which should be considered when using hepcidin measurements for diagnostic purposes in women of child-bearing potential
Published: 2016
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28. Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy

Author: Fabien Robin, Hélène Beloeil, Karim Boudjema, Bruno Laviolle, Laurent Sulpice, Bernard Meunier, Elodie Gaignard, Michel Rayar, Aude Merdrignac, Damien Bergeat, CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Population, 030230 surgery, Nasogastric Decompression, Pancreaticoduodenectomy, law.invention, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, Clinical endpoint, Humans, Medicine, Prospective Studies, education, Intubation, Gastrointestinal, Aged, education.field_of_study, Gastric emptying, business.industry, Pancreatic Diseases, Postoperative complication, Length of Stay, Middle Aged, Decompression, Surgical, 3. Good health, Surgery, 030220 oncology & carcinogenesis, Female, France, business, Abdominal surgery
Abstract: International audience; Importance - Although standardization of pancreaticoduodenectomy (PD) has improved postoperative outcomes, morbidity remains high. Fast-track surgery programs appear to improve morbidity, and avoiding nasogastric tube decompression (NGTD), already outdated in most major abdominal surgery, is strongly suggested after PD by fast-track surgery programs but lacks high-level evidence, especially regarding safety. Objective - To assess in a randomized clinical trial whether the absence of systematic NGTD after PD reduces postoperative complications. Design, setting, and participants - The IPOD study (Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy) was an open-label, prospective, single-center, randomized clinical trial conducted at a high-volume pancreatic surgery university hospital in France. In total, 155 patients who were 18 to 75 years of age and required PD for benign or malignant disease were screened for study eligibility. Key exclusion criteria were previous gastric or esophageal surgery and severe comorbidities. Patients were randomly assigned (1:1) to systematic NGTD or to no nasogastric decompression and were followed up until 90 days after surgery. Interventions - For patients without NGTD, the NGT was removed immediately after surgery, whereas for patients with NGTD, the NGT was removed 3 to 5 days after surgery. Main outcomes and measures - The primary end point was the occurrence of postoperative complications grade II or higher using the Clavien-Dindo classification. The primary end point and safety were evaluated in the intent-to-treat population. Results - From January 2016 to August 2018, 125 screened patients were considered eligible for the study, and 111 were randomized to no NGTD (n = 52) or to NGTD (n = 59). No patient was lost to follow-up. The 2 groups had similar patient demographic and clinical characteristics at baseline. The median (interquartile range) age was 63.0 (57.0-66.5) years in the group with NGTD (38 [64.4%] were males) and 64.0 (58.0-68.0) years in the group without NGTD (31 [59.6%] were males). The postoperative complication rates grade II or higher were similar between the 2 groups (risk ratio, 0.99; 95% CI, 0.66-1.47; P > .99). Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups. Median (interquartile) length of hospital stay for patients without NGTD was not significantly different compared with those with NGTD (10.0 [9.0-16.3] vs 12.0 [10.0-16.0] days; P = .14). Conclusions and relevance - The present study found no significant difference in postoperative complication occurrence of Clavien-Dindo classification grade II or higher between systematic NGTD and no NGTD after PD, suggesting that avoiding systematic nasogastric decompression is safe for this indication. Trial registration - ClinicalTrials.gov Identifier: NCT02594956.
Published: 2020
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29. Serum hCG threshold to assess medical abortion success

Author: Maela Le Lous, Bruno Laviolle, Vincent Lavoué, Lucas Peltier, Krystel Nyangoh Timoh, Anne-Claire Gallinand, CHU Pontchaillou [Rennes], Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes - Faculté de Médecine (UR Médecine), Université de Rennes (UR), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: First trimester, Adult, endocrine system, medicine.medical_specialty, [SDV]Life Sciences [q-bio], medicine.medical_treatment, hCG, Gestational Age, Chorionic Gonadotropin, Human chorionic gonadotropin, 03 medical and health sciences, 0302 clinical medicine, Serum hcg, Pregnancy, Reference Values, Ongoing pregnancy, Outcome Assessment, Health Care, Odds Ratio, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, reproductive and urinary physiology, Abortifacient Agents, Nonsteroidal, pregnancy outcome, 030219 obstetrics & reproductive medicine, urogenital system, business.industry, Obstetrics, Obstetrics and Gynecology, Abortion, Induced, Medical abortion, Mifepristone, Pregnancy Trimester, First, medical abortion, Logistic Models, Treatment Outcome, Reproductive Medicine, embryonic structures, Female, business, hormones, hormone substitutes, and hormone antagonists, Misoprostol
Abstract: International audience; Objectives The main aim of the study was to establish a threshold for serum human chorionic gonadotropin (hCG) level that ruled out ongoing pregnancy after induced medical abortion (MA). The secondary aim was to discover risk factors for the need for uterine aspiration. Methods This prospective study included women who underwent MA with mifepristone-misoprostol at = 900 IU/l to diagnose ongoing pregnancy gave 100% sensitivity and 81.5% specificity, compared with 85.7% sensitivity and 83.5% specificity using a threshold >= 1000 IU/l. Independent risk factors for uterine aspiration requirement were gravidity (OR 3.8; 95% CI 1.1, 13.2; p = .001), gestational age >6 weeks (OR 6.0; 95% CI 1.8, 6.0; p = .006) and previous surgical abortion (OR 2.4; 95% CI 1.1, 5.2; p < .001). Conclusion Serum hCG measurement
Published: 2019
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30. Consumption of a Carbonated Beverage with High-Intensity Sweeteners Has No Effect on Insulin Sensitivity and Secretion in Nondiabetic Adults

Author: Fabrice Lainé, Mélanie Viltard, Bruno Laviolle, Maxime Esvan, Aude Tavenard, Fabrice Bonnet, Eve M. Lepicard, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for European Expertise in Physiology (Paris, France), Coca-Cola Company (USA), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 0301 basic medicine, Male, Non-Nutritive Sweeteners, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Thiazines, Medicine (miscellaneous), Carbonated Beverages, Overweight, chemistry.chemical_compound, 0302 clinical medicine, Reference Values, Aspartame, sweeteners, Matsuda Insulin Sensitivity Index, 2. Zero hunger, Nutrition and Dietetics, Cross-Over Studies, 3. Good health, Female, medicine.symptom, Adult, medicine.medical_specialty, insulin, Blood sugar, 030209 endocrinology & metabolism, 03 medical and health sciences, Insulin resistance, Double-Blind Method, Internal medicine, Diabetes mellitus, medicine, Diabetes Mellitus, Humans, insulin sensitivity, 030109 nutrition & dietetics, business.industry, Insulin, Feeding Behavior, medicine.disease, Crossover study, Diet, glycemia, Endocrinology, Glucose, chemistry, Insulin Resistance, business, Body mass index
Abstract: International audience; Background The effects of the regular intake of beverages containing high-intensity sweeteners on insulin sensitivity in healthy individuals remain controversial. Objective This trial compared the effects of the consumption of a carbonated beverage containing aspartame and acesulfame K (high-intensity sweeteners beverage-HISB) with those of an unsweetened, no-calorie carbonated beverage (UB) on insulin sensitivity and secretion in nondiabetic adults. Methods SEDULC was a randomized, double-blind, crossover study. Nondiabetic adults [mean age 31 y, 44% men, body mass index (BMI; kg/m(2)) 19-29] who did not consume high-intensity sweeteners were randomized 1 1 to drink 1 of the 2 carbonated beverages, 2 cans (330 mL each)/d, for 12 wk. After a 4-wk washout period, participants were switched to the opposite beverage for 12 wk. The primary outcome tested was the change in insulin sensitivity as assessed by the Matsuda Insulin Sensitivity Index (MISI) after an oral glucose load. Secondary outcomes were indexes of insulin secretion. Results Sixty individuals were enrolled and 50 completed the study (28 nonoverweight and 22 overweight participants). The change in MISI from baseline did not significantly differ between beverages and noninferiority was demonstrated (difference = -0.23; 95% CI -1.31, 0.85; P < 0.0001). The change in insulinogenic (means +/- SEMs 0.23 +/- 0.14 for HISB compared with 0.08 +/- 0.1 for UB) and disposition indexes (2.70 +/- 0.99 for HISB compared with 1.62 +/- 0.90 for UB) did not differ, and no differences in insulin secretion estimates were confirmed by the Stumvoll indexes. Consuming the high-intensity sweeteners did not affect body weight, self-reported dietary consumption, or self-reported physical activity. Conclusions These findings suggest that the daily consumption of 2 cans of a beverage containing aspartame and acesulfame K over 12 wk has no significant effect on insulin sensitivity and secretion in nondiabetic adults. This trial was registered at clinicaltrials.gov as NCT02031497.
Published: 2018
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31. Effects of antibiotic prophylaxis on ventilator-associated pneumonia in severe traumatic brain injury. A post hoc analysis of two trials

Author: Claire Dahyot-Fizelier, Philippe Seguin, Chloé Rousseau, Antoine Roquilly, Florian Reizine, Bruno Laviolle, Karim Asehnoune, Matthieu Arnouat, CHU Pontchaillou [Rennes], Centre hospitalier universitaire de Nantes (CHU Nantes), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Male, medicine.medical_specialty, Traumatic brain injury, [SDV]Life Sciences [q-bio], Critical Care and Intensive Care Medicine, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Internal medicine, Post-hoc analysis, Brain Injuries, Traumatic, medicine, Ventilator-associated pneumonia, Humans, Multicenter Studies as Topic, Antibiotic prophylaxis, Hydrocortisone, Retrospective Studies, business.industry, Incidence (epidemiology), Incidence, Pneumonia, Ventilator-Associated, 030208 emergency & critical care medicine, Antibiotic Prophylaxis, Middle Aged, bacterial infections and mycoses, medicine.disease, respiratory tract diseases, 3. Good health, Pneumonia, On ventilator, 030228 respiratory system, Female, business, medicine.drug
Abstract: International audience; Purpose To investigate the role of antibiotic prophylaxis (AP) in the incidence of ventilator-associated pneumonia (VAP) in patients suffering from traumatic brain injury (TBI). Materials and methods This post hoc analysis was conducted based on data from 2 multicentre double-blind studies that aimed to prevent VAP using hydrocortisone or povidone iodine. Data from TBI patients were extracted and pooled. Patients were classified into 2 groups those who received an AP (AP group) and those who did not (control group). Results 295 patients were included (AP group, n = 146; control group, n = 149). The incidence of VAP was 145 (49%). VAP incidence was lower in the AP group (39% vs 59%, Relative Risk = 0.33, 95%CI, 0.19–0.56, p = 0.001). Time to VAP occurrence was delayed (Hazard Ratio = 0.50, 95%CI 0.36–0.69, p < 0.001). The incidence of early VAP (>2 and ≤ 5 days) was lower in the AP group (10% vs 32%; p < 0.001), whereas that of late VAP (>5 days) did not differ (AP group 29% vs control group 28%; p = 0.811). Length of stay and mortality did not differ between the 2 groups. Conclusions Early use of AP delayed and may prevent the occurrence of VAP in severe TBI patients but did not change length of stay or mortality. © 2018 Elsevier Inc.
Published: 2018
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32. Effect of Continuous versus Intermittent Subglottic Suctioning on Tracheal Mucosa by the Mallinckrodt TaperGuard Evac Oral Tracheal Tube in Intensive Care Unit Ventilated Patients: A Prospective Randomized Study

Author: Romain Corre, Yoann Launey, Marie Tiercin, Bruno Laviolle, Philippe Seguin, Harmonie Perrichet, G. Brinchault, Estelle Le Pabic, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1, Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Suction (medicine), business.operation, medicine.medical_treatment, mechanical ventilation, Critical Care and Intensive Care Medicine, Tracheal tube, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, intubation, law.invention, 03 medical and health sciences, 0302 clinical medicine, Bronchoscopy, law, Intensive care, medicine, Intubation, tracheal injury, Mechanical ventilation, medicine.diagnostic_test, business.industry, 030208 emergency & critical care medicine, Mallinckrodt, Intensive care unit, 3. Good health, subglottic secretion drainage, 030228 respiratory system, Anesthesia, business, Research Article
Abstract: International audience; Background and Aims: A risk of tracheal mucosa injury induced by subglottic suctioning has been raised. Therefore, this prospective randomized study aims to compare the effect of continuous suctioning of subglottic secretions versus intermittent suctioning of subglottic secretions (CSSS vs. ISSS) secretions on tracheal mucosa in front of the suctioning port of the endotracheal tube.Patients and Methods: Patients requiring intubation or reintubation in Intensive Care Unit with an expected ventilation duration > 24 h were eligible. Participants received CSSS at -20 mmHg or ISSS at -100 mmHg during 15 s and no suction during 8 s. The effect on tracheal mucosa in front of the suction port was assessed after intubation (T0) and before extubation (T1) using bronchoscopy. Tracheal mucosa damages were graded into five categories (no injury, erythema, edema, ulceration, or necrosis). The occurrence (no injury observed at T0 but present at T1) or the worsening (injury observed at T0 exacerbating at T1) was studied.Results: Seventy-three patients were included and 53 patients (CSSS, n = 26 and ISSS, n = 27) were evaluable on the primary endpoint. The occurrence or worsening of tracheal mucosal damages did not differ between the two groups (CSSS, n = 7 [27%] vs. ISSS, n = 5 [17%], P = 0.465). Daily average volume of suctioned secretion was higher with ISSS (74 ± 100 ml vs. 20 ± 25 ml, P < 0.001). Impossibility to aspirate was higher with CSSS (0.14 ± 0.16 per day vs. 0.03 ± 0.07 per day, P < 0.001).Conclusions: Our results suggest that tracheal mucosal damages did not differ between CSSS and ISSS. The aspirated volume was higher and impossibility to aspirate was lower with ISSS.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01555229.
Published: 2018
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33. A prospective study of the frequency of severe pain and predictive factors in women undergoing first-trimester surgical abortion under local anaesthesia

Author: Solène Duros, Vincent Lavoué, Jean Levêque, Krystel Nyangoh Timoh, Paul Lemeut, Yolaine Joueidi, Aude Tavenard, Laurence Boyer, Bruno Laviolle, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Local anaesthesia, medicine.medical_specialty, [SDV.OT]Life Sciences [q-bio]/Other [q-bio.OT], Multivariate analysis, Visual analogue scale, [SDV]Life Sciences [q-bio], Population, Surgical abortion, 03 medical and health sciences, 0302 clinical medicine, medicine, Severe pain, 030212 general & internal medicine, education, Prospective cohort study, education.field_of_study, 030219 obstetrics & reproductive medicine, Obstetrics, business.industry, Obstetrics and Gynecology, 3. Good health, Reproductive Medicine, Secondary Outcome Measure, Gestation, Population study, business, Predictive factor
Abstract: International audience; Objective - To determine the frequency of severe pain among women and to identify the associated predictive factors during first-trimester surgical abortion under local anaesthesia (LA).Study design - A prospective cohort study from November 2013 to January 2014 at the Department of Gynecology and Obstetrics, Rennes, France. The study population was composed of one hundred and ninety-four patients who underwent an elective first-trimester surgical abortion under LA. In an anonymized questionnaire, the participants were asked to self-record their perceived pain level 30 min after the completion of the procedure using a 10 cm visual analogue scale (VAS). The main outcome measure was the frequency of severe pain among women, defined as VAS ≥ 7. Secondary outcome measure was the risk factor(s) for severe pain.Results - Severe pain (i.e. VAS ≥ 7) was experienced by 46% (95% CI: 39%-53%) of the population. Multivariate analysis confirmed that >10 weeks of gestation (OR: 2.530 [95% CI: 1.1-5.81], p = .0287) and having 0 or 1 child (OR: 5.206 [95% CI: 1.87-14.49], p = .0016) were significant independent factors of severe pain.Conclusion - Nearly half of the women experienced severe pain. More than 10 weeks of gestation and parity were predictive factors of severe pain. These findings should be useful in counselling women undergoing surgical abortion under LA.
Published: 2018
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34. Local Anesthetics Inhibit the Growth of Human Hepatocellular Carcinoma Cells

Author: Cédric Coulouarn, Bruno Clément, Gaëlle Angenard, Bruno Laviolle, Grégoire Le Gac, Hélène Beloeil, Foie, métabolismes et cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent
Subjects: Oncology, Time Factors, Messenger, Apoptosis, Cell Cycle Proteins, 0302 clinical medicine, 030202 anesthesiology, dose response, time factor, Medicine, genetics, Anesthetics, Local, Cyclin B1, G2 phase cell cycle checkpoint, Cellular Senescence, ropivacaine, Tumor, Caspase 3, messenger RNA, Liver Neoplasms, Cell cycle, 3. Good health, Gene Expression Regulation, Neoplastic, G2 Phase Cell Cycle Checkpoints, Local, Cell Aging, 030220 oncology & carcinogenesis, Drug, Cell aging, medicine.medical_specialty, liver cell carcinoma, liver tumor, Carcinoma, Hepatocellular, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Cell Survival, CASP3 protein, local anesthetic agent, [SDV.CAN]Life Sciences [q-bio]/Cancer, Cell Line, Dose-Response Relationship, 03 medical and health sciences, [SDV.CAN] Life Sciences [q-bio]/Cancer, cell cycle protein, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Internal medicine, Cell Line, Tumor, Humans, RNA, Messenger, human, Progenitor cell, Anesthetics, Cell Proliferation, Neoplastic, Dose-Response Relationship, Drug, business.industry, Cell growth, Gene Expression Profiling, Carcinoma, tumor cell line, Lidocaine, Hepatocellular, Amides, amide, Anesthesiology and Pain Medicine, Gene Expression Regulation, drug effects, Cancer cell, Cancer research, RNA, pathology, business, metabolism, Cyclin A2
Abstract: International audience; BACKGROUND: Hepatocellular carcinoma (HCC) is an aggressive cancer with limited therapeutic options. Retrospective studies have shown that the administration of local anesthetics (LAs) during cancer surgery could reduce cancer recurrence. Besides, experimental studies reported that LAs could inhibit the growth of cancer cells. Thus, the purpose of this study was to investigate the effects of LAs on human HCC cells.METHODS: The effects of 2 LAs (lidocaine and ropivacaine) (10 to 10 M) were studied after an incubation of 48 hours on 2 HCC cell lines, namely HuH7 and HepaRG. Cell viability, cell cycle analysis, and apoptosis and senescence tests were performed together with unsupervised genome-wide expression profiling and quantitative real-time polymerase chain reaction for relevant genes.RESULTS: We showed that LAs decreased viability and proliferation of HuH7 cells (from 92% [P < .001] at 5 × 10 M to 40% [P = .02] at 10 M with ropivacaine and from 87% [P < .001] to 37% [P = .02] with lidocaine) and HepaRG progenitor cells (from 58% at 5 × 10 M [P < .001] to 29% at 10 M [P = .04] with lidocaine and 59% [P < .001] with ropivacaine 5 × 10 M) in concentration-dependent manner. LAs have no effect on well-differentiated HepaRG. Ropivacaine decreased the mRNA level of key cell cycle regulators, namely cyclin A2, cyclin B1, cyclin B2, and cyclin-dependent kinase 1, and the expression of the nuclear marker of cell proliferation MKI67. Lidocaine had no specific effect on cell cycle but increased by 10× the mRNA level of adenomatous polyposis coli (P < .01), which acts as an antagonist of the Wnt/β-catenin pathway. Both LAs increased apoptosis in Huh7 and HepaRG progenitor cells (P < .01).CONCLUSIONS: The data demonstrate that LAs induced profound modifications in gene expression profiles of tumor cells, including modulations in the expression of cell cycle-related genes that result in a cytostatic effect and induction of apoptosis.
Published: 2017
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35. Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study

Author: Edouard Bardou-Jacquet, Olivier Loréal, Caroline Jezequel, Martine Ropert, Nicolas Collet, Fabrice Lainé, Jeff Morcet, Catherine Hamon, Nadia Fatih, Bruno Laviolle, Jean-Michel Reymann, Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Inserm (Institut National de la Santé et de la Recherche Médicale). DGOS (Direction Générale de l'Offre de Soins. Ministère de la santé et des affaires sociales, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Blood Glucose, Male, 0301 basic medicine, medicine.medical_specialty, Anemia, Administration, Oral, Pilot Projects, Placebo, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Hepcidins, Hepcidin, Internal medicine, hemic and lymphatic diseases, medicine, Humans, Pharmacology (medical), iron metabolism, Curcuma, Pharmacology, chemistry.chemical_classification, Cross-Over Studies, medicine.diagnostic_test, biology, Plant Extracts, business.industry, Transferrin saturation, curcuma, biology.organism_classification, medicine.disease, Crossover study, 3. Good health, 030104 developmental biology, Endocrinology, chemistry, healthy volunteers, Transferrin, 030220 oncology & carcinogenesis, Immunology, Serum iron, biology.protein, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, hepcidin, business, Biomarkers
Abstract: International audience; Hepcidin, secreted by hepatocytes, controls iron metabolism by limiting iron egress in plasma. Hepcidin is upregulated during inflammation through the activation of the signal transducer and activator of transcription 3 (STAT3) transduction pathway, which decreases iron bioavailability and may explain the anemia of chronic inflammatory disease. In vitro, it has been shown that curcumin can decrease hepcidin synthesis by decreasing STAT3 activity. We conducted a proof-of-concept study to assess the effect of curcuma on hepcidin synthesis in human. This was a placebo-controlled, randomized, double-blind, cross-over, two-period study performed in 18 healthy male volunteers. Subjects received a single oral dose of 6 g curcuma containing 2% of curcumin or placebo. Serum hepcidin and iron parameters were assessed repeatedly until 48 h after dosing. When compared with a placebo curcuma decreased hepcidin levels significantly at 6 h (−19%, P = 0.004), 8 h (−17%, P = 0.009), and 12 h (−17%, P = 0.007) and tended to decrease hepcidin at 24 h (−15%, P = 0.076). Curcuma also significantly increased serum ferritin levels at 6 and 8 h (+7% for both times, P = 0.018, 0.030, respectively) and had no effects on serum iron, transferrin, and transferrin saturation. This pilot study showed that curcuma decreases serum hepcidin levels in human and supports the idea that curcuma could be useful in treating hepcidin overproduction during inflammatory processes. Confirmatory studies in patients with chronic inflammation are now required to determine the optimal dose and therapeutic scheme of curcuma.
Published: 2017
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36. Low doses of fludrocortisone and hydrocortisone, alone or in combination, on vascular responsiveness to phenylephrine in healthy volunteers

Author: Pascale Le Maguet, Erwan Donal, Bruno Laviolle, Eric Bellissant, and Fabrice Lainé
Subjects: Pharmacology, Mean arterial pressure, business.industry, Fludrocortisone, Context (language use), 030204 cardiovascular system & hematology, Placebo, Crossover study, 3. Good health, Norepinephrine (medication), 03 medical and health sciences, 0302 clinical medicine, Anesthesia, medicine, Pharmacology (medical), 030212 general & internal medicine, business, Phenylephrine, medicine.drug, Hydrocortisone
Abstract: AIMS: A single administration of hydrocortisone has been shown to enhance the pressor response to phenylephrine in healthy volunteers and to norepinephrine in septic shock patients. Similar data do not exist for fludrocortisone. Since there continues to be disagreement about the utility of fludrocortisone in septic shock, we assessed the effects of a single administration of low doses of hydrocortisone (50 mg intravenously) and fludrocortisone (50 μg orally), given either alone or in combination, on phenylephrine mean arterial pressure and cardiac systolic and diastolic function dose-response relationships in 12 healthy male volunteers with hypo-aldosteronism induced by intravenous sodium loading. METHODS: This was a placebo-controlled, randomized, double-blind, crossover study performed according to a 2 × 2 factorial design. Subjects received first a 2000 ml infusion of NaCl 0.9% during 2 h. Then fludrocortisone 50 μg (or its placebo) was administered orally and hydrocortisone 50 mg (or its placebo) was injected intravenously. At 1.5 h after treatment administration, incremental doses of phenylephrine were infused (from 0.01 to 3 μg kg(-1) min(-1)), each dose being infused during 5 min. RESULTS: Both fludrocortisone (P < 0.001) and hydrocortisone (P = 0.002) induced a significant decrease in pressor response to phenylephrine, their effects being additive (fludrocortisone × hydrocortisone interaction, P = 0.792). The two drugs did not induce any detectable cardiac effect. CONCLUSIONS: Single administrations of fludrocortisone and hydrocortisone decreased the pressor response to phenylephrine in healthy volunteers with hypo-aldosteronism. These similar effects of hydrocortisone and fludrocortisone probably express a rapid non-genomic vasodilating effect of the two steroids in the context of acute volume loading.
Published: 2013
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37. Effectiveness and complications of ultrasound-guided subclavian vein cannulation in children and neonates

Author: François de la Brière, Claude Ecoffey, Anne Defontaine, Charlotte Engrand, Bruno Laviolle, Sabrina Dessard, Cécile Gauvrit, Nicolas Nardi, Severine Delahaye, Eric Wodey, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'anesthésie réanimation chirurgicale [Rennes], Université de Rennes (UR)-Hôpital Pontchaillou, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Brenner, Nelly, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Pontchaillou-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
Subjects: Male, medicine.medical_specialty, Endpoint Determination, [SDV]Life Sciences [q-bio], Subclavian, Anesthesia, General, Critical Care and Intensive Care Medicine, Subclavian Vein, Catheterization, Central venous, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, 030202 anesthesiology, Catheterization, Peripheral, medicine, Humans, General anaesthesia, Prospective Studies, Treatment Failure, Child, Children, Ultrasonography, Interventional, Ultrasonography, Catheter insertion, business.industry, Incidence (epidemiology), Infant, Newborn, Infant, 030208 emergency & critical care medicine, General Medicine, Arteries, medicine.disease, 3. Good health, Surgery, [SDV] Life Sciences [q-bio], Anesthesiology and Pain Medicine, Pneumothorax, Brachiocephalic, Anesthesia, Child, Preschool, Cohort, Observational study, Female, Complication, business, Subclavian vein
Abstract: International audience; Background The ultrasound (US)-guided supraclavicular approach to subclavian vein (Sup-SCV) catheterisation in children has recently been described and evaluated in a small cohort. The aim of this study was to assess this technique in a large paediatric cohort including neonates. Methods We conducted a prospective observational study between November 2010 and December 2013 which included 615 children divided into two groups according to their weight: Group 1 ≤ 5 kg (n = 124), Group 2 > 5 kg (n = 491). All procedures were performed under general anaesthesia by an anaesthesiologist or a supervised resident. The success rates of catheter insertion, the number of punctures required, the procedure time, and the complication rates were analysed. Results Sup-SCV catheterisation was successful in 98% of the cases and was higher in Group 2 than in Group 1 (99.4% versus 92.7%, P
Published: 2016
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38. Cerebral Microdialysis Effects of Propofol versus Midazolam in Severe Traumatic Brain Injury

Author: M. Tanguy, Yannick Mallédant, Bruno Laviolle, Philippe Seguin, Jean-Paul Bleichner, Xavier Morandi, Service d'anesthésie réanimation chirurgicale [Rennes], Université de Rennes (UR)-Hôpital Pontchaillou, Pharmacologie du Sepsis et Choc Septique, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes]-CHU Pontchaillou [Rennes]-Service de réanimation chirurgicale, Université de Rennes (UR)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service de neurochirurgie [Rennes] = Neurosurgery [Rennes], CHU Pontchaillou [Rennes], Le Corre, Morgane, Hôpital Pontchaillou-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Foie, métabolismes et cancer, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Service de Pharmacologie [Rennes], and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes]
Subjects: Glycerol, Male, Microdialysis, medicine.medical_treatment, 0302 clinical medicine, MESH: Hypnotics and Sedatives, Pyruvic Acid, Hypnotics and Sedatives, Single-Blind Method, MESH: Microdialysis, MESH: Brain Chemistry, 030212 general & internal medicine, Propofol, Cerebral Cortex, Glutamate receptor, MESH: Neuroprotective Agents, MESH: Glutamic Acid, 3. Good health, MESH: Glucose, Neuroprotective Agents, MESH: Propofol, Anesthesia, Female, medicine.symptom, medicine.drug, Adult, Traumatic brain injury, Midazolam, Sedation, Glutamic Acid, Neuroprotection, 03 medical and health sciences, MESH: Glycerol, medicine, Humans, Lactic Acid, MESH: Pyruvic Acid, Brain Chemistry, MESH: Humans, business.industry, Vitamin E, MESH: Biological Markers, MESH: Adult, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, MESH: Single-Blind Method, medicine.disease, MESH: Male, MESH: Cerebral Cortex, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Glucose, Brain Injuries, MESH: Midazolam, MESH: Brain Injuries, MESH: Lactic Acid, Neurology (clinical), business, MESH: Female, Biomarkers, 030217 neurology & neurosurgery
Abstract: International audience; Propofol, an anesthetic agent acting as an analogue of vitamin E, has been advocated to be an ideal neuroprotective agent both in animal models and in clinical practice, due to its positive effects on oxidative stress. Nevertheless, no studies have compared this agent to another sedative agent used for sedation after traumatic brain injury (TBI). The objective was to compare the effects of propofol to midazolam on cerebral biomarkers at the acute phase of severe TBI patients. Thirty patients aged 35±18 years were prospectively randomized to receive propofol or midazolam and 29 were analyzed (n=15 for propofol, and n=14 for midazolam). A cerebral microdialysis catheter was used to measure the lactate:pyruvate (L:P) ratio, glutamate, glycerol, and glucose for 72 h. No difference between groups was observed for the L:P ratio (time effect p=0.201, treatment effect p=0.401, time×treatment interaction p=0.101). Similarly, no difference was observed for glutamate (time effect p=0.930, treatment effect p=0.651, time×treatment interaction p=0.353), glycerol (time effect p=0.223, treatment effect p=0.922, time×treatment interaction p=0.308), or glucose (time effect p=0.116, treatment effect p=0.088, time×treatment interaction p=0.235). These results do not support a difference between propofol and midazolam for sedation for the cerebral metabolic profile in severe TBI.
Published: 2012
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39. Impact de l’âge sur la mortalité des patients traumatisés médullaires hospitalisés en réanimation

Author: Philippe Seguin, Yannick Mallédant, P. Le Maguet, A. Godard, Bruno Laviolle, and Yoann Launey
Subjects: medicine.medical_specialty, Multivariate analysis, Traumatic spinal cord injury, business.industry, Mortality rate, General Medicine, Functional Independence Measure, Intensive care unit, 3. Good health, law.invention, 03 medical and health sciences, 0302 clinical medicine, Anesthesiology and Pain Medicine, medicine.anatomical_structure, law, Internal medicine, Intensive care, medicine, Sphincter, Functional status, 030212 general & internal medicine, business, 030217 neurology & neurosurgery
Abstract: Objective To evaluate the impact of age (< or ≥ 65 ans) on hospital mortality in traumatic spinal cord injury requiring intensive care. Design Retrospective, monocenter. Patients and methods A total of 131 patients greater or equal to 15 years (< 65 years, n = 109 and ≥ 65 years, n = 22) was analyzed (cervical, n = 71; thoracolumbar, n = 60), over a 10 years period (1998-2008). The hospital and long-term mortality were studied. The risks factors of death were searched by a uni- and multivariate analysis. Intensive care unit (ICU) discharge and long-term neurological recovery, and long-term functional independence measure (FIM) were assessed. Results Hospital mortality was increased in patients greater or equal to 65 years (41% vs 6%, P < 0.001) and long term mortality was not different between the two groups (31% vs 12%, P = 0.150). The risks factors of death were age (HR = 3.44; IC 95%: 1.53-7.72, P = 0.028), previous coronary disease (HR = 3.64; IC 95%: 1.25-10.65; P = 0.018) and fall injury (HR = 2.40; IC 95%: 1.15-5.00, P = 0.020). Among survivors, incompletes forms (Frankel B, C, D, E) were significantly more frequent in older patients at ICU discharge and long term follow up. At long term, FIM was similar in the two groups except a better sphincter control in patient greater or equal to 65 years. Conclusion Mortality rate of older people (≥ 65 years) were greater than those in younger people, mainly caused by an increased hospital mortality. Among survivors, the neurological recovery was better in patients' greater or equal to 65 years, and was associated with a functional status at least comparable than in the youngest patients.
Published: 2012
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40. Effect of an anesthesia with propofol compared with desflurane on free radical production and liver function after partial hepatectomy

Author: Yannick Mallédant, David Aguillon, Eric Bellissant, Cédric Basquin, Philippe Seguin, Isabelle Morel, Karim Boudjema, Philippe Compagnon, Valérie Turmel, and Bruno Laviolle
Subjects: Pharmacology, Prothrombin time, medicine.diagnostic_test, Lidocaine, Chemistry, medicine.medical_treatment, Malondialdehyde, 3. Good health, 03 medical and health sciences, Desflurane, chemistry.chemical_compound, 0302 clinical medicine, 030202 anesthesiology, 030220 oncology & carcinogenesis, Anesthesia, medicine, Pharmacology (medical), Liver function, Hepatectomy, Propofol, Liver function tests, medicine.drug
Abstract: Propofol has shown antioxidant properties, but no study has focused on liver resection surgery. The aim of this study was to investigate the effect of an anesthesia with propofol compared with desflurane on oxidative stress and hepatic function during and after partial hepatectomy. This was a prospective randomized study performed on two parallel groups. The primary endpoint was malondialdehyde (MDA) plasma concentration 30 min after hepatic vascular unclamping. Hepatic damages were evaluated by plasma levels of alpha-glutathione S-transferase (α-GST) 120 min after hepatic vascular unclamping and of aminotransferases at 120 min and on days 1, 2, 5, and 10. Liver function recovery was assessed by monoethylglycinexylidide (MEGX) formation 15 min after lidocaine injection on day 2 and by prothrombin time and plasma factor V at 120 min and on days 1, 2, 5, and 10. Thirty patients were analyzed (propofol group: 17; desflurane group: 13). There was no significant difference between groups for MDA plasma concentration 30 min after hepatic vascular unclamping (mean ± standard-deviation: 1.28 ± 0.40 and 1.21 ± 0.29 in propofol and desflurane groups, respectively, P = 0.608). Plasma levels of α-GST at 120 min were lower in propofol than in desflurane group (142.2 ± 75.4 vs. 205.7 ± 66.5, P = 0.023), and MEGX on day 2 was higher (0.092 ± 0.096 vs. 0.036 ± 0.020, P = 0.007). No differences between groups were observed with regard to plasma levels of aminotransferases, prothrombin time, and plasma factor V. Our study showed that in patients undergoing partial hepatectomy, propofol did not reduce MDA formation but seemed to display a protective effect on hepatic damages and liver function when compared to desflurane.
Published: 2011
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41. Effectiveness of simple daily sensitization of physicians to the duration of central venous and urinary tract catheterization

Author: Aurélie Coué, Philippe Seguin, Sonia Isslame, Yannick Mallédant, Bruno Laviolle, Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Pharmacologie du Sepsis et Choc Septique, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes]-CHU Pontchaillou [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Service de Pharmacologie [Rennes]
Subjects: Male, Time Factors, medicine.medical_treatment, Urinary tract catheter, Critical Care and Intensive Care Medicine, 0302 clinical medicine, Infection rate, Interquartile range, Prospective Studies, MESH: Incidence, 030212 general & internal medicine, Practice Patterns, Physicians', Prospective cohort study, Cross Infection, MESH: Catheterization, Central Venous, 0303 health sciences, MESH: Middle Aged, Incidence, Incidence (epidemiology), Middle Aged, Duration of catheterization, 3. Good health, Intensive Care Units, Catheter, Anesthesia, Female, Urinary Catheterization, Central venous catheter, Catheterization, Central Venous, Critical Care, Reminder Systems, Urinary system, MESH: Reminder Systems, Urinary catheterization, 03 medical and health sciences, Intensive care, medicine, Humans, MESH: Intensive Care, MESH: Physician's Practice Patterns, MESH: Humans, 030306 microbiology, business.industry, MESH: Time Factors, MESH: Cross Infection, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, MESH: Prospective Studies, MESH: Male, MESH: Urinary Catheterization, MESH: Intensive Care Units, business, MESH: Female
Abstract: International audience; PURPOSE: To evaluate the effectiveness of simple daily sensitization of physicians to the duration of central venous and urinary tract catheterization, and impact on infection rates. METHODS: A prospective, before-after study in a surgical intensive care unit. All consecutive patients who had a central venous catheter (CVC) and/or urinary tract catheter (UTC) were included during two consecutive periods. Period 1 (August 2005 to May 2006) served as the control period. During Period 2 (July 2006 to April 2007), a red square, added to the patient's daily care sheet, questioned the physician about the utility of the CVC and/or UTC. If the response was "No", the CVC and/or the UTC were removed by a nurse. RESULTS: A total of 1,271 patients were analyzed (Period 1, n = 676; Period 2, n = 595). The duration of catheterization (median [interquartile range]) was significantly reduced in Period 2 compared to Period 1 (from (5 [3-9] to 4 [3-7] days, p < 0.001, for CVC, and from 5 [3-11] to 4 [3-8] days, p < 0.001, for UTC). The incidence and density incidence of CVC infection decreased in Period 2 compared to Period 1 (from 1.8% to 0.3%, p = 0.010, and from 2.8 to 0.7/1,000 CVC-days, p = 0.051) whereas UTC infections were not significantly different (4.3 to 3.0%, p = 0.230, and 5.0 to 4.9/1,000 UTC-days, p = 0.938, respectively). CONCLUSIONS: A simple daily reminder to physicians on the patients' care sheets decreased the duration of central venous and urinary tract catheterization, and tended to decrease CVC infection rate without affecting UTC infection.
Published: 2010
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42. Incidence of atrial fibrillation during very long-term follow-up after radiofrequency ablation of typical atrial flutter

Author: Philippe Mabo, Aude Solnon, Gaelle Kervio, Ghassan Moubarak, Bruno Laviolle, Dominique Pavin, Jean-Claude Daubert, Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, Flutter atrial, Time Factors, Radiofrequency ablation, Kaplan-Meier Estimate, Atrial flutter, 030204 cardiovascular system & hematology, law.invention, 0302 clinical medicine, [INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing, Risk Factors, Interquartile range, law, Typical atrial flutter, Prevalence, Ablation par radiofréquence, Left atrial enlargement, Prospective Studies, 030212 general & internal medicine, Ejection fraction, Incidence, Hazard ratio, Atrial fibrillation, General Medicine, Middle Aged, Treatment Outcome, Catheter Ablation, Cardiology, Female, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Cardiology and Cardiovascular Medicine, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing, medicine.medical_specialty, Risk Assessment, Disease-Free Survival, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, Fibrillation atriale, medicine, Humans, Aged, Proportional Hazards Models, business.industry, medicine.disease, Surgery, business, Follow-Up Studies
Abstract: International audience; Background Radiofrequency ablation is an effective treatment for typical atrial flutter (AFL) but long-term results may be hampered by atrial fibrillation (AF). Aims To determine the incidence and predictors of AF during very long-term follow-up after radiofrequency ablation of typical AFL. Methods From November 1998 to December 2000, patients who underwent successful radiofrequency ablation for cavotricuspid isthmus-dependent AFL in our centre were followed prospectively. Results Of the 135 patients followed (mean age: 62 ± 11 years), 69 (51%) had structural heart disease. Mean left ventricular ejection fraction was 52 ± 11%. Patients were analysed according to preablation AF history: group 1 included patients with AFL (N = 71); group 2 included patients with AFL and AF (N = 64). During a median [interquartile range] follow-up of 7.8 [7.0-8.4] years, new-onset or recurrent AF was experienced by 99 (73%) patients: 44 (62%) in group 1 and 55 (86%) in group 2. Although most episodes occurred in the first 2 years postablation, AF prevalence increased continuously over time. Preablation AF history predicted AF occurrence (hazard ratio: 2.10, 95% confidence interval: 1.40-3.14; p = 0.001), as did left atrial diameter (hazard ratio: 1.05 per 1 mm increase; 95% confidence interval: 1.02-1.08; p < 0.001). AF evolved to become permanent in 24% of group 1 and 47% of group 2 patients (p = 0.005). Conclusion During long-term follow-up, most patients will experience AF after ablation of typical AFL. Preablation AF history and left atrial enlargement predict postablation AF occurrence.
Published: 2009
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43. Sustained positive impact of a coronary rehabilitation programme on adherence to dietary recommendations

Author: Karine Ligier, François Paillard, Bruno Laviolle, Jean-Claude Daubert, Catherine Letellier, Pascal Guillo, Christèle Froger-Bompas, Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Counseling, Male, Health Knowledge, Attitudes, Practice, Time Factors, medicine.medical_treatment, MESH: Health Knowledge, Attitudes, Practice, MESH: Food Habits, Réadaptation, Ascorbic Acid, Coronary Artery Disease, 030204 cardiovascular system & hematology, MESH: Erythrocyte Membrane, Gastroenterology, 0302 clinical medicine, MESH: Practice Guidelines as Topic, [INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing, Surveys and Questionnaires, MESH: Ascorbic Acid, MESH: Coronary Artery Disease, 030212 general & internal medicine, MESH: Treatment Outcome, 2. Zero hunger, chemistry.chemical_classification, MESH: Program Evaluation, MESH: Middle Aged, Biological markers, Rehabilitation, MESH: Counseling, MESH: Fatty Acids, Unsaturated, General Medicine, Middle Aged, MESH: Nutrition Assessment, MESH: Nutritional Status, MESH: Patient Compliance, Dietary advice, Lipids, 3. Good health, Coronary heart disease, Erythrocyte membrane, Treatment Outcome, MESH: Risk Reduction Behavior, Practice Guidelines as Topic, Fatty Acids, Unsaturated, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Marqueurs biologiques, Cardiology and Cardiovascular Medicine, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing, Polyunsaturated fatty acid, Adult, medicine.medical_specialty, Prévention, Group ii, Nutritional Status, MESH: Patient Education as Topic, MESH: Folic Acid, 03 medical and health sciences, Folic Acid, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Patient Education as Topic, Internal medicine, medicine, Humans, In patient, Nutrition, MESH: Humans, Vitamin C, Questionnaire, business.industry, MESH: Questionnaires, Prevention, MESH: Time Factors, Erythrocyte Membrane, MESH: Biological Markers, MESH: Adult, Feeding Behavior, MESH: Lipids, MESH: Male, Diet, Surgery, Maladie coronaire, Nutrition Assessment, chemistry, Patient Compliance, business, Risk Reduction Behavior, Biomarkers, Program Evaluation
Abstract: International audience; BACKGROUND: Nutrition has a major influence after coronary events but long-term adherence to dietary advice is poorly evaluated. AIM: To evaluate if a cardiovascular rehabilitation programme including dietary counselling has a positive impact on adherence to dietary recommendations. METHODS: Two groups of coronary patients were compared in an observational non-randomized study. Group I included 32 patients at the acute phase of a coronary syndrome and group II included 104 patients between six months and three years after completing a cardiovascular rehabilitation programme. The evaluation was performed with (1) a validated 14-item food frequency questionnaire (FFQ), which gives scores for the consumption of saturated fatty acids (SFA), monounsaturated fatty acids (MUFA), Omega-6 and Omega-3 polyunsaturated fatty acids (PUFA), fruits and vegetables, and a global cardiovascular protective dietary score; and (2) biological markers. RESULTS: SFA score was higher in group I vs II (7.4+/-2.8 vs 4.4+/-2.1, p
Published: 2009
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44. Variations of hepcidin and iron-status parameters during the menstrual cycle in healthy women

Author: Yves Deugnier, Sylvie Sacher-Huvelin, Bruno Laviolle, Edouard Bardou-Jacquet, Emmanuelle Comets, Martine Ropert, Adeline Angeli, Karine Lacut, Caroline Jezequel, Fabrice Lainé, Valérie Gissot, Audrey Lavenu, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Foie, métabolismes et cancer, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre de référence des surcharges en fer rares d'origine génétique, CHU Pontchaillou [Rennes], Service des Maladies de l'Appareil Digestif, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], CIC - Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC, Institut des Maladies de l'Appareil Digestif, University Hospital, Faculté de médecine, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Service de Pharmacologie [Rennes], Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC), Protéines de la membrane érythrocytaire et homologues non-érythroides, Université des Antilles et de la Guyane (UAG)-Institut National de la Transfusion Sanguine [Paris] (INTS)-Université Paris Diderot - Paris 7 (UPD7)-Université de La Réunion (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Projet Inter-régional Hospitalier de Recherche Clinique 2013, Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Service des Maladies de l'Appareil Digestif [CHU Rennes], Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Rennes - Faculté de Médecine (UR Médecine), Université de Rennes (UR), and Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 0301 basic medicine, Adult, Adolescent, media_common.quotation_subject, [SDV]Life Sciences [q-bio], Iron, Hepcidin, Bioinformatics, 03 medical and health sciences, Young Adult, Hepcidins, Medicine, Humans, iron metabolism, Menstrual cycle, ComputingMilieux_MISCELLANEOUS, Menstrual Cycle, media_common, biology, business.industry, Hematology, Middle Aged, haemoglobin, Healthy Volunteers, 3. Good health, 030104 developmental biology, biology.protein, Female, Iron status, business
Abstract: International audience; no abstract
Published: 2015
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45. Risks and Benefits of Nalmefene in the Treatment of Adult Alcohol Dependence: A Systematic Literature Review and Meta-Analysis of Published and Unpublished Double-Blind Randomized Controlled Trials

Author: Jean Michel Reymann, Rémy Boussageon, Bruno Laviolle, Florian Naudet, Eric Bellissant, Clément Palpacuer, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Centre hospitalier universitaire de Poitiers (CHU Poitiers), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, Narcotic Antagonists, [SDV]Life Sciences [q-bio], Poison control, Cochrane Library, Placebo, Risk Assessment, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Humans, 030212 general & internal medicine, Nalmefene, Randomized Controlled Trials as Topic, business.industry, Alcohol dependence, General Medicine, Naltrexone, 3. Good health, Surgery, Alcoholism, Treatment Outcome, Relative risk, Meta-analysis, Medicine, business, 030217 neurology & neurosurgery, Research Article, medicine.drug
Abstract: Background Nalmefene is a recent option in alcohol dependence treatment. Its approval was controversial. We conducted a systematic review and meta-analysis of the aggregated data (registered as PROSPERO 2014:CRD42014014853) to compare the harm/benefit of nalmefene versus placebo or active comparator in this indication. Methods and Findings Three reviewers searched for published and unpublished studies in Medline, the Cochrane Library, Embase, ClinicalTrials.gov, Current Controlled Trials, and bibliographies and by mailing pharmaceutical companies, the European Medicines Agency (EMA), and the US Food and Drug Administration. Double-blind randomized clinical trials evaluating nalmefene to treat adult alcohol dependence, irrespective of the comparator, were included if they reported (1) health outcomes (mortality, accidents/injuries, quality of life, somatic complications), (2) alcohol consumption outcomes, (3) biological outcomes, or (4) treatment safety outcomes, at 6 mo and/or 1 y. Three authors independently screened the titles and abstracts of the trials identified. Relevant trials were evaluated in full text. The reviewers independently assessed the included trials for methodological quality using the Cochrane Collaboration tool for assessing risk of bias. On the basis of the I2 index or the Cochrane’s Q test, fixed or random effect models were used to estimate risk ratios (RRs), mean differences (MDs), or standardized mean differences (SMDs) with 95% CIs. In sensitivity analyses, outcomes for participants who were lost to follow-up were included using baseline observation carried forward (BOCF); for binary measures, patients lost to follow-up were considered equal to failures (i.e., non-assessed patients were recorded as not having responded in both groups). Five randomized controlled trials (RCTs) versus placebo, with a total of 2,567 randomized participants, were included in the main analysis. None of these studies was performed in the specific population defined by the EMA approval of nalmefene, i.e., adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women). No RCT compared nalmefene with another medication. Mortality at 6 mo (RR = 0.39, 95% CI [0.08; 2.01]) and 1 y (RR = 0.98, 95% CI [0.04; 23.95]) and quality of life at 6 mo (SF-36 physical component summary score: MD = 0.85, 95% CI [−0.32; 2.01]; SF-36 mental component summary score: MD = 1.01, 95% CI [−1.33; 3.34]) were not different across groups. Other health outcomes were not reported. Differences were encountered for alcohol consumption outcomes such as monthly number of heavy drinking days at 6 mo (MD = −1.65, 95% CI [−2.41; −0.89]) and at 1 y (MD = −1.60, 95% CI [−2.85; −0.35]) and total alcohol consumption at 6 mo (SMD = −0.20, 95% CI [−0.30; −0.10]). An attrition bias could not be excluded, with more withdrawals for nalmefene than for placebo, including more withdrawals for safety reasons at both 6 mo (RR = 3.65, 95% CI [2.02; 6.63]) and 1 y (RR = 7.01, 95% CI [1.72; 28.63]). Sensitivity analyses showed no differences for alcohol consumption outcomes between nalmefene and placebo, but the weight of these results should not be overestimated, as the BOCF approach to managing withdrawals was used. Conclusions The value of nalmefene for treatment of alcohol addiction is not established. At best, nalmefene has limited efficacy in reducing alcohol consumption., In a systematic review and meta-analysis, Florian Naudet and colleagues assess whether medication with the opioid antagonist nalmefene can reduce consumption and other outcomes of alcohol addiction., Editors' Summary Background Many people enjoy an occasional alcoholic drink. But because alcohol is an addictive substance, some people (around one in 12 people in the US, for example) develop alcohol dependency (alcoholism). Such people have an excessive desire to drink or have lost control over their alcohol use, and may find it hard to relax or enjoy themselves without having a drink. As well as becoming psychologically dependent on alcohol, they can become physically dependent and may show withdrawal symptoms such as sweating, shaking, and nausea—or even delirium tremens, a psychotic condition that involves tremors, hallucinations, anxiety, and disorientation—when they attempt to reduce their drinking. Indeed, severely dependent drinkers often drink to relieve their withdrawal symptoms (“relief drinking”). Although alcohol dependency sometimes runs in families, it can also be triggered by stressful events, and the condition can damage health, emotional stability, finances, careers, and relationships. Why Was This Study Done? To reduce harm, alcohol-dependent individuals are usually advised to abstain from drinking, but controlled (moderate) drinking may also be helpful. To help people reduce their alcohol consumption, the European Medicines Agency recently approved nalmefene—a drug that blocks the body’s opioid receptors and reduces the craving for alcohol—for use in the treatment of alcohol dependence in adults who consume more than 60 g (for men) or 40 g (for women) of alcohol per day (a small glass of wine contains about 12 g of alcohol; a can of beer contains about 16 g). However, several expert bodies have concluded that nalmefene shows no benefit over naltrexone, an older treatment for alcohol dependency, and do not recommend its use for this indication. Here, the researchers investigate the risks and benefits of nalmefene in the treatment of alcohol dependency in adults by undertaking a systematic review and meta-analysis of double-blind randomized controlled trials (RCTs) of nalmefene for this indication. A systematic review uses predefined criteria to identify all the research on a given topic, and a meta-analysis combines the results of several studies; a double-blind RCT compares outcomes in people chosen at random to receive different treatments without the researchers or the participants knowing who received which treatment until the end of the trial. What Did the Researchers Do and Find? The researchers identified five RCTs that met the criteria for inclusion in their study. All five RCTs (which involved 2,567 participants) compared the effects of nalmefene with a placebo (dummy drug); none was undertaken in the population specified by the European Medicines Agency approval. Among the health outcomes examined in the meta-analysis, there were no differences between participants taking nalmefene and those taking placebo in mortality (death) after six months or one year of treatment, in the quality of life at six months, or in a summary score indicating mental health at six months. The RCTs included in the meta-analysis did not report other health outcomes such as accidents. Participants taking nalmefene had fewer heavy drinking days per month at six months and one year of treatment than participants taking placebo, and their total alcohol consumption was lower. However, more people withdrew from the nalmefene groups than from the placebo groups, often for safety reasons. Thus, attrition bias—selection bias caused by systematic differences between groups in withdrawals from a study that can affect the accuracy of the study’s findings—cannot be excluded. Indeed, when the researchers undertook an analysis in which they allowed for withdrawals, the alcohol consumption outcomes did not differ between the treatment groups. What Do These Findings Mean? These findings show that there is no high-grade evidence currently available from RCTs to support the use of nalmefene for harm reduction among people being treated for alcohol dependency. In addition, they provide little evidence to support the use of nalmefene to reduce alcohol consumption among this population. Thus, the value of nalmefene for the treatment of alcohol addiction is not established. Importantly, these findings reveal a lack of information on clinically relevant outcomes in the evidence that led to nalmefene approval by the European Medicines Agency. Thus, these findings also call into question the decisions of this and other regulatory and advisory bodies that have approved nalmefene on the basis of the available evidence from RCTs, and highlight the need for further RCTs of nalmefene compared to placebo and naltrexone for the indication specified in the market approval. Additional Information This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at http://dx.doi.org/10.1371/journal.pmed.1001924. The US National Institute on Alcohol Abuse and Alcoholism has information about alcohol and its effects on health (including alcohol use disorder, another name for alcohol dependency); it provides interactive worksheets to help people evaluate their drinking and decide whether and how to make a change The UK National Health Service Choices website provides detailed information about drinking and alcohol and about alcohol dependency (including a personal story about alcohol misuse), and tools for calculating alcohol consumption The US National Council on Alcoholism and Drug Dependence provides information about alcohol addiction and a self-test for alcohol dependence Drinkaware is a UK-based non-profit organization that aims to improve the UK’s drinking habits; its website provides information on alcohol dependence and on other aspects of alcohol and health, and a tool for calculating alcohol intake MedlinePlus provides links to many other resources on alcohol and on alcoholism and alcohol abuse Wikipedia has pages on nalmefene and on naltrexone (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages) Details of the European Medicine Agency approval of nalmefene are available More information about this study is available
Published: 2015
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46. The Accuracy of Transcutaneous PCO2 in Subjects With Severe Brain Injury: A Comparison With End-Tidal PCO2

Author: Philippe Seguin, Jean-Paul Bleichner, Bruno Laviolle, Alice Jouve, Yoann Launey, Sébastien Rosier, Yannick Mallédant, Foie, métabolismes et cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Service de réanimation chirurgicale, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service d'anesthésie réanimation chirurgicale [Rennes], Hôpital Pontchaillou-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UR)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Université de Rennes (UR)-Hôpital Pontchaillou, and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Male, Pulmonary and Respiratory Medicine, [SDV]Life Sciences [q-bio], Respiratory monitoring, Critical Care and Intensive Care Medicine, Transcutaneous pco2, pCO2, 03 medical and health sciences, 0302 clinical medicine, Respiratory Rate, Predictive Value of Tests, Tidal Volume, Humans, Arterial blood gas analysis, Medicine, In patient, Prospective Studies, business.industry, Limits of agreement, 030208 emergency & critical care medicine, General Medicine, Middle Aged, Arterial catheter, End tidal pco2, Respiration, Artificial, respiratory tract diseases, 030228 respiratory system, Brain Injuries, Anesthesia, Regression Analysis, Female, Nuclear medicine, business, Blood Gas Monitoring, Transcutaneous, circulatory and respiratory physiology
Abstract: International audience; BACKGROUND: In patients suffering from brain injury, end-tidal PCO2 (PETCO2 ) monitoring is controversial, but transcutaneous PCO2 (PtcCO2 ), which is noninvasive and utilizes immediate display, may be an alternative method. We hypothesized that PtcCO2 would be more accurate than PETCO2 for monitoring PaCO2 in patients with severe brain injury. METHODS: A prospective observational study included consecutive mechanically ventilated adult subjects who had acute brain injury and an arterial catheter in place. When an arterial blood gas analysis was required, the PETCO2 and PtcCO2 values were simultaneously recorded. The agreement between the PETCO2 , PtcCO2 , and PaCO2 measurements (reference) was determined using the Bland-Altman method. The number of outliers defined by the formula ([PETCO2 or PtcCO2 ] - PaCO2 ) \textgreater ± 4 mm Hg indicated the proportion of measurements that were considered clinically unacceptable. RESULTS: A total of 25 subjects were included in the study, and 85 simultaneous measurements of PaCO2 , PtcCO2 , and PETCO2 were obtained. The bias and precision between PaCO2 and PtcCO2 were -0.75 and 6.23 mm Hg, respectively. The limits of agreement ranged from -12.97 to 11.47 mm Hg. The bias and precision between PaCO2 and PETCO2 were 0.68 and 5.82 mm Hg, respectively. The limits of agreement ranged from -10.72 to 12.08 mm Hg. There were 34 (40%) outliers for the PtcCO2 sensor and 34 (40%) outliers for the PETCO2 sensor (P \textgreater .99). CONCLUSIONS: The accuracy of PtcCO2 was not superior to that of PETCO2 for assessing PCO2 levels and should not be used to monitor these levels in subjects with severe brain injury.
Published: 2014
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47. Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial

Author: Philippe, Seguin, Bruno, Laviolle, Claire, Dahyot-Fizelier, Romain, Dumont, Benoit, Veber, Soizic, Gergaud, Karim, Asehnoune, Olivier, Mimoz, Pierre-Yves, Donnio, Eric, Bellissant, Yannick, Malledant, Eddy, Lebas, Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Modélisations pharmacocinétiques-pharmacodynamiques pour un meilleur usage des anti-infectieux, Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Anesthésie-Réanimation [CHU Limoges], CHU Limoges, Service de réanimation médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service d'anesthésie et réanimation chirurgicale, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Unité de contrôle infectieux, Université de Rennes (UR)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study and AtlanRéa Groups., Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Poitiers, Hôpital Charles Nicolle [Rouen]-CHU Rouen, and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes]
Subjects: Male, medicine.medical_specialty, medicine.medical_treatment, povidone-iodine, Population, Oropharynx, intensive care medicine, Critical Care and Intensive Care Medicine, Placebo, 03 medical and health sciences, ventilator-associated pneumonia, 0302 clinical medicine, Double-Blind Method, prevention, Internal medicine, Intensive care, medicine, Clinical endpoint, Humans, 030212 general & internal medicine, education, Cerebral Hemorrhage, Mechanical ventilation, education.field_of_study, business.industry, oral care, Respiratory disease, Ventilator-associated pneumonia, Pneumonia, Ventilator-Associated, 030208 emergency & critical care medicine, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Middle Aged, medicine.disease, Respiration, Artificial, 3. Good health, Surgery, Intensive Care Units, Pneumonia, Brain Injuries, Anti-Infective Agents, Local, Female, business
Abstract: International audience; OBJECTIVE: To evaluate the efficacy and safety of oral care with povidone-iodine on the occurrence of ventilator-associated pneumonia in a high-risk population. DESIGN: A multicenter, placebo-controlled, randomized, double-blind, two-parallel-group trial performed between May 2008 and May 2011. SETTING: Six ICUs in France. PATIENTS: One hundred seventy-nine severely brain-injured patients (Glasgow Coma Scale ≤ 8) or cerebral hemorrhage expected to be mechanically ventilated for more than 24 hours. INTERVENTIONS: Participants were randomly assigned to receive oropharyngeal care with povidone-iodine (n = 91) or placebo (n = 88) six times daily until mechanical ventilation withdrawal. MEASUREMENTS AND MAIN RESULTS: Primary endpoint was the rate of ventilator-associated pneumonia. Secondary endpoint included the rates of ventilator-associated tracheobronchitis and acute respiratory distress syndrome and patient's outcome. The number of patients evaluable for the primary endpoint (preplanned modified intention-to-treat population) was 150 (78 in the povidone-iodine group, 72 in the placebo group). Ventilator-associated pneumonia occurred in 24 patients (31%) in the povidone-iodine group and 20 (28%) in the placebo group (relative risk, 1.11 [95% CI, 0.67-1.82]; p = 0.69). There was no significant difference between the two groups for ventilator-associated tracheobronchitis: eight patients (10%) in the povidone-iodine group and five patients (7%) in the placebo group (relative risk, 1.48 [95% CI, 0.51-4.31]; p = 0.47). Acute respiratory distress syndrome occurred in five patients in the povidone-iodine group but not in the placebo group (p = 0.06). There was no difference between groups for ICU and hospital lengths of stay, as well as ICU and 90-day mortality. CONCLUSIONS: There is no evidence to recommend oral care with povidone-iodine to prevent ventilator-associated pneumonia in high-risk patients. Furthermore, this strategy seems to increase the rate of acute respiratory distress syndrome.
Published: 2014
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48. Surgical treatment of esophageal perforations: the importance of a primary repair

Author: Bruno Laviolle, Michel Rayar, Bernard Meunier, Karim Boudjema, Diane Cunin, Laurent Sulpice, Aude Merdrignac, Service de Chirurgie Hépatobiliaire et Digestive [Rennes] = Hepatobiliary and Digestive Surgery [Rennes], CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Le Corre, Morgane, and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Prosthesis, 03 medical and health sciences, Primary repair, 0302 clinical medicine, Surgical oncology, Esophageal perforation, Absorbable Implants, medicine, Resorbable prosthesis, Humans, Surgical treatment, Polyglactin 910, Aged, Retrospective Studies, Sutures, business.industry, Suture Techniques, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, General Medicine, Middle Aged, Surgical Mesh, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, 3. Good health, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, business
Abstract: International audience; PURPOSE: The aim of the current study was to evaluate the outcome after primary repair in comparison to other surgical treatments and the advantage of reinforcing the sutures with an absorbable polyglactin 910 prosthesis. METHODS: All esophageal perforations surgically managed in this institution from January 1985 through April 2009 (n = 40) were retrospectively analyzed. Patients that underwent surgery with primary sutures (group A, n = 24) were compared with patients that received other surgical procedures (group B, n = 16). The time to initiate treatment (within or after the first 24 h) and if the suture was reinforced with a polyglactin 910 mesh were also analyzed in group A patients. RESULTS: The outcome was more favorable in group A than group B in terms of time in the intensive care unit (p = 0.005), and rate of reoperation (p = 0.005). There was no difference in the outcome after the primary suture with or without mesh reinforcement, although the rate of fistulization was lower in patients with a mesh (17 vs. 50 %, p = 0.19). CONCLUSIONS: Primary repair has a better outcome than other surgical treatment, even when performed more than 24 h after symptom onset, but not later than 48 h. Reinforcing the sutures with an absorbable polyglactin 910 mesh therefore seems to improve the outcome.
Published: 2013
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49. Subthalamic nucleus modulates social and anxogenic-like behaviors

Author: Bruno Laviolle, Stephan Saikali, Morgane Pihan, Danièle Bentué-Ferrer, Jean-Michel Reymann, Florian Naudet, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Service des explorations fonctionnelles neurologiques, CHU Pontchaillou [Rennes], Laboratoire d'Anatomopathologie, Pharmacologie du Sepsis et Choc Septique, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), Rennes 1 University UFR of Medicine, Jonchère, Laurent, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR), Service des explorations fonctionnelles [CHU Rennes], Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 - Faculté de Médecine (UR1 Médecine), Université de Rennes - Faculté de Médecine (UR Médecine), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes - Faculté de Médecine (UR Médecine)
Subjects: STN, Male, Elevated plus maze, Parkinson's disease, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Stimulation, Anxiety, Lesion, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, Subthalamic Nucleus, Basal ganglia, medicine, Animals, Interpersonal Relations, Social behavior, Rats, Wistar, 030304 developmental biology, Elevated Plus Maze, 0303 health sciences, Parkinson's Disease, [SDV.NEU.NB] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, medicine.disease, Rats, Subthalamic nucleus, Disease Models, Animal, Hindlimb Suspension, Exploratory Behavior, Linear Models, PD, medicine.symptom, Psychology, Neuroscience, EPM, 030217 neurology & neurosurgery
Abstract: The sponsor had no role concerning: design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. There are no conflicts of interest regarding this paper.; International audience; In Parkinson's disease, global social maladjustment and anxiety are frequent after subthalamic nucleus (STN) stimulation and are generally considered to be linked with sociofamilial alterations induced by the motor effects of stimulation. We hypothesized that the STN is per se involved in these changes and aimed to explore the role of STN in social and anxogenic-like behaviors using an animal model. Nineteen male Wistar rats with bilateral lesions of the STN were compared with 26 sham-lesioned rats by synchronizing an ethological approach based upon direct observation of social behaviors and a standardized approach, the elevated plus maze (EPM). Comparisons between groups were performed by a Mann-Whitney-Wilcoxon test. Lesioned rats showed impairments in their social (P=0.05) and aggressive behaviors with a diminution of attacking (P=0.04) and chasing (P=0.06). In the EPM, concerning the open arms, the percentage of distance, time, inactive time, and entry were significantly decreased in lesioned rats (P=0.02, P=0.01, P=0.04, and P=0.05). The time spent in non-protected head dips was also diminished in the lesioned rats (P=0.01). These results strongly implicate the STN in social behavior and anxogenic-like behavior. In human, as DBS induces changes in the underlying dynamics of the stimulated brain networks, it could create an abnormal brain state in which anxiety and social behavior are altered. These results highlight another level of complexity of the behavioral changes after stimulation.
Published: 2013
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50. Caesarean section at term: the relationship between neonatal respiratory morbidity and microviscosity in amniotic fluid

Author: Laure-Anne Haumont, Helene Isly, Pierre Bétrémieux, Bruno Laviolle, Patrick Pladys, Claude Bendavid, Patrice Poulain, Karine Morcel, Marie Pascale Beaumont, Linda Lassel, Laure Voguet, Caroline Piau, Vincent Lavoué, Estelle Bauville, Foie, métabolismes et cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Service de Gynécologie et Obstétrique [Rennes] = Gynaecology [Rennes], CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de pharmacologie clinique, Laboratoire de biochimie générale, Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service de Pédiatrie, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Male, medicine.medical_specialty, Amniotic fluid, Adolescent, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Fluorescence Polarization, Respiratory morbidity, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Pregnancy, 030225 pediatrics, Surfactant, Medicine, Humans, Caesarean section, Prospective Studies, Phospholipids, Fluorescence polarisation, Retrospective Studies, 2. Zero hunger, Fetus, Respiratory Distress Syndrome, Newborn, 030219 obstetrics & reproductive medicine, business.industry, Vaginal delivery, Obstetrics, Cesarean Section, Viscosity, Infant, Newborn, Obstetrics and Gynecology, Gestational age, Odds ratio, Middle Aged, Amniotic Fluid, Confidence interval, Microviscosity, Reproductive Medicine, Gestation, Female, business
Abstract: None of the authors report any conflicts of interest.; International audience; OBJECTIVES: The incidence of neonatal respiratory morbidity following an elective caesarean section is 2-3 times higher than after a vaginal delivery. The microviscosity of surfactant phospholipids, as measured with fluorescence polarisation, is linked with the functional characteristics of fetal surfactant and thus fetal lung maturity, but so far this point has received little attention in new-borns at term. The aim of the study is to evaluate the correlation between neonatal respiratory morbidity and amniotic microviscosity (Fluorescence Polarisation Index) in women undergoing caesarean section after 37 weeks' gestation. STUDY DESIGN: The files of 136 women who had undergone amniotic microviscosity studies during elective caesarean deliveries at term were anonymised. Amniotic fluid immaturity (AFI) was defined as a Fluorescence Polarisation Index higher than 0.335. RESULTS: Respiratory morbidity was observed in 10 babies (7.3%) and was independently associated with AFI (OR: 6.11 [95% CI, 1.20-31.1] with p=0.029) and maternal body mass index (OR: 1.12 [95% CI, 1.02-1.22] with p=0.019). Gestational age at the time of caesarean delivery was inversely associated with AFI (odds ratio, 0.46 [95% confidence interval, 0.29-0.71], p
Published: 2012
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