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1. Extended prone positioning duration for COVID-19-related ARDS: benefits and detriments

Author

Thaïs Walter, Noémie Zucman, Jimmy Mullaert, Ingrid Thiry, Coralie Gernez, Damien Roux, and Jean-Damien Ricard

Subjects
Prone positioning, Pressure injuries, COVID-19-related ARDS, Mechanical ventilation, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background During the COVID-19 pandemic, many more patients were turned prone than before, resulting in a considerable increase in workload. Whether extending duration of prone position may be beneficial has received little attention. We report here benefits and detriments of a strategy of extended prone positioning duration for COVID-19-related acute respiratory distress syndrome (ARDS). Methods A eetrospective, monocentric, study was performed on intensive care unit patients with COVID-19-related ARDS who required tracheal intubation and who have been treated with at least one session of prone position of duration greater or equal to 24 h. When prone positioning sessions were initiated, patients were kept prone for a period that covered two nights. Data regarding the incidence of pressure injury and ventilation parameters were collected retrospectively on medical and nurse files of charts. The primary outcome was the occurrence of pressure injury of stage ≥ II during the ICU stay. Results For the 81 patients included, the median duration of prone positioning sessions was 39 h [interquartile range (IQR) 34–42]. The cumulated incidence of stage ≥ II pressure injuries was 26% [95% CI 17–37] and 2.5% [95% CI 0.3–8.8] for stages III/IV pressure injuries. Patients were submitted to a median of 2 sessions [IQR 1–4] and for 213 (94%) prone positioning sessions, patients were turned over to supine position during daytime, i.e., between 9 AM and 6 PM. This increased duration was associated with additional increase in oxygenation after 16 h with the PaO2/FiO2 ratio increasing from 150 mmHg [IQR 121–196] at H+ 16 to 162 mmHg [IQR 124–221] before being turned back to supine (p = 0.017). Conclusion In patients with extended duration of prone position up to 39 h, cumulative incidence for stage ≥ II pressure injuries was 26%, with 25%, 2.5%, and 0% for stage II, III, and IV, respectively. Oxygenation continued to increase significantly beyond the standard 16-h duration. Our results may have significant impact on intensive care unit staffing and patients’ respiratory conditions. Trial registration: Institutional review board 00006477 of HUPNVS, Université Paris Cité, APHP, with the reference: CER-2021-102, obtained on October 11th 2021. Registered at Clinicaltrials (NCT05124197).

Published
2022
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2. Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis (RECORDS): study protocol for a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial

Author

Shidasp Siami, Charlène Le Moal, Thomas DAIX, Sylvie Chevret, Yonatan Perez, Constance Vuillard, Damien Roux, Jonathan Messika, Stephan Ehrmann, Jean-Pierre Quenot, Dalila Benzekri, Gwenhaël Colin, Thierry Boulain, Julie Mankikian, Laura Federici, Jean Reignier, Jean-Paul Mira, Marie-Ange Azais, Djillali Annane, Jean-Claude Lacherade, Grégoire Muller, Christine Lebert, Nicholas Heming, Arthur Bailly, Emmanuelle Mercier, Jean-Baptiste Lascarrou, Julio Badie, Louis-Marie Dumont, Gaetan Plantefeve, Francis Schneider, Patrice Tirot, Isabelle Vinatier, Mickael Landais, Michel Djibré, Bruno Francois, Alexandra Monnier, Francois Barbier, Ferhat Meziani, Hamid Merdji, Pascal Andreu, Julie Helms, Laetitia Bodet-Contentin, Nicolas Pichon, Noémie Zucman, Mehran Monchi, Xavier Monnet, Marie Labruyère, Denis Garot, Hassène Rahmani, Jérôme Fleuriet, Pierre-Louis Declerq, Adrien Robine, Fabrice Uhel, Charles Cerf, Gilles Troché, Alexandrou Antigoni, Annane Djillali, Arlt Birte, Badie Julio, Benghanem Sarah, Berdaguer Ferrari Fernando, Cerf Charles, Chelly Dagdia Zaineb, Chevret Sylvie, Colin Gwenhaël, Daniel Christel, Declercq Pierre-Louis, Delbove Agathe, Devillier Philippe, Fleuriet Jérome, François Bruno, Garchon Henri-Jean, Godot Véronique, Grassin-Delyle Stanislas, Grisolia Mathieu, Guitton Christophe, Helms Julie, Heming Nicholas, Herzog Marielle, Kamel Toufik, Kedad Zoubida, Lassalle Philippe, Lhermite Guillaume, Megarbane Bruno, Mekontso Dessap Armand, Mercier Emmanuelle, Meziani Ferhat, Mira Jean-Paul, Monchi Mehran, Monnet Xavier, Muller Grégoire, Quenot Jean-Pierre, Reignier Jean, Robine Adrien, Rottman Martin, Roux Anne-Laure, Schneider Francis, Siami Shidasp, Tissieres Pierre, Troché Gilles, Uhel Fabrice, Zeitouni Karine, Plantefève Gaëtan, Walid Darwiche, Antoine Guillon, Youenn Jouan, Annick Legras, Marlene Morisseau, Emmanuelle Rouve, Charlotte Salmon-Gandonniere, Raphael Clere-Jehl, Laure Stiel, Antoine Studer, Jean-Baptiste Roudaut, Marine Jacquier, Sophie Jacquier, Armelle Mathonnet, Mai-Anh Nai, Isabelle Runge, Sophie Tollec, Marc Amouretti, Pierre Moine, Paris Meng, Rania Bounab, Muriel-Sarah Fartoukh, Alexandre Elabbadi, Konstantinos Bachoumas, Remi Bernardon, Gauthier Blonz, Luc Desmedt, Brian Emonet, Maud Fiancette, Matthieu Henry, Julien Lorber, Laurent Martin-Lefevre, Caroline Pouplet, Aihem Yehia, Sarah Benghanem, Julien Charpentier, Clara Vigneron, Anne-Laure Fedou, Claire Mancia, Emmanuelle Begot, Philippe Vignon, Antoine Galy, Celine Gonzalez, Marine Goudelin, Bruno Evrard, Arnaud Desachy, Julien Vaidie, Guillaume Gilbert, Cedric Darreau, Benoit Derrien, Marjorie Saint-Martin, Nicolas Chudeau, Jean Christophe Callahan, Dominique Vivier, Pierre-Yves Olivier, Remy Marnai, Nicolas Sedillot, Xavier Tchenio, Yves Poncelin, Remi Bruyere, Grimaldi Lamiae, and Derridj Nawal

Subjects
Medicine
Abstract

Introduction Corticosteroids affect variably survival in sepsis trials, suggesting heterogeneity in patients’ response to corticosteroids. The RECORDS (Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis) trial aimed at defining endotypes associated with adults with sepsis responsiveness to corticosteroids.Methods and analysis RECORDS, a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial, will randomly assign to a biomarker stratum 1800 adults with community-acquired pneumonia, vasopressor-dependent sepsis, septic shock or acute respiratory distress syndrome. In each stratum, patients will be randomly assigned to receive a 7-day course of hydrocortisone and fludrocortisone or their placebos. Patients with COVID-19 will be treated with a 10-day standard course of dexamethasone and randomised to fludrocortisone or its placebo. Primary outcome will be 90-day death or persistent organ dysfunction. Large simulation study will be performed across a range of plausible scenarios to foresee power to detect a 5%–10% absolute difference with corticosteroids. We will assess subset-by-treatment interaction by estimating in a Bayesian framework two quantities: (1) measure of influence, relying on the value of the estimation of corticosteroids’ effect in each subset, and (2) measure of interaction.Ethics and dissemination The protocol was approved by the Ethics Committee (Comité de Protection des Personnes, Dijon, France), on 6 April 2020. Trial results will be disseminated at scientific conferences and results will be published in peer-reviewed journals.Trial registration number ClinicalTrials.gov Registry (NCT04280497).

Published
2023
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3. Comparison of standard prophylactic, intermediate prophylactic and therapeutic anticoagulation in patients with severe COVID-19: protocol for the ANTICOVID multicentre, parallel-group, open-label, randomised controlled trial

Author

Étienne Audureau, Vincent Labbe, Bruno Megarbane, Jean-François Timsit, Damien Contou, Emmanuel Vivier, Martin Dres, Muriel Fartoukh, Keyvan Razazi, Nicholas Heming, Bertrand Souweine, Armand Mekontso Dessap, Guillaume Voiriot, Denis Doyen, Florence Boissier, Noémie Zucman, Mehran Monchi, Hafid Ait-Oufella, Serge Carreira, Alexandre Robert, Mohamed Fejjal, Sebastien Preau, Elise Noel-Savina, Santiago Alberto Picos, William Juguet, Eric Mariotte, Matthieu Turpin, Ségolène Gendreau, and Samia Baloul

Subjects
Medicine
Abstract

Introduction COVID-19 induces venous, arterial and microvascular thrombosis, involving several pathophysiological processes. In patients with severe COVID-19 without macrovascular thrombosis, escalating into high-dose prophylactic anticoagulation (HD-PA) or therapeutic anticoagulation (TA) could be beneficial in limiting the extension of microvascular thrombosis and forestalling the evolution of lung and multiorgan microcirculatory dysfunction. In the absence of data from randomised trials, clinical practice varies widely.Methods and analysis This is a French multicentre, parallel-group, open-label, randomised controlled superiority trial to compare the efficacy and safety of three anticoagulation strategies in patients with COVID-19. Patients with oxygen-treated COVID-19 showing no pulmonary artery thrombosis on computed tomography with pulmonary angiogram will be randomised to receive either low-dose PA, HD-PA or TA for 14 days. Patients attaining the extremes of weight and those with severe renal failure will not be included. We will recruit 353 patients. Patients will be randomised on a 1:1:1 basis, and stratified by centre, use of invasive mechanical ventilation, D-dimer levels and body mass index. The primary endpoint is a hierarchical criterion at day 28 including all-cause mortality, followed by the time to clinical improvement defined as the time from randomisation to an improvement of at least two points on the ordinal clinical scale. Secondary outcomes include thrombotic and major bleeding events at day 28, individual components of the primary endpoint, number of oxygen-free, ventilator-free and vasopressor-free days at day 28, D-dimer and sepsis-induced coagulopathy score at day 7, intensive care unit and hospital stay at day 28 and day 90, and all-cause death and quality of life at day 90.Ethics and dissemination The study has been approved by an ethical committee (Ethics Committee, Ile de France VII, Paris, France; reference 2020-A03531-38). Patients will be included after obtaining their signed informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04808882.

Published
2022
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4. Hydrocortisone plus fludrocortisone for community acquired pneumonia-related septic shock: a subgroup analysis of the APROCCHSS phase 3 randomised trial

Author

Djillali, ANNANE, Christian, BRUN-BUISSON, Benoit, MISSET, Jean, CHASTRE, François, BRIVET, Julien, BOHE, Carole, SCHWEBEL, Shidasp, SIAMI, Michel, SLAMA, Olivier, LEROY, Gilles, CAPELLIER, Michel, WOLFF, Mohamed, ALI BEN ALI, François, ANTONINI, Jean-François, LORIFERNE, Franck, PETITPAS, Claire, CHARPENTIER, Jean-Michel, CONSTANTIN, Gilles, D'HONNEUR, Bertrand, SOUWEINE, Xavier, FORCEVILLE, Bruno, MEGARBANE, Francois, BAUDIN, Gwenhaël, COLIN, Karim, ASEHNOUNE, Jean-Pierre, QUENOT, Bruno, FRANCOIS, Thierry, BOULAIN, Emmanuelle, MERCIER, Jean, REIGNIER, Roland, AMATHIEU, Fabrice, COOK, Alain, CARIOU, Loic, CHIMOT, Fouad, Fadel, Andrea, Polito, Bernard, Clair, Virginie, Maxime, David, Luis, Tarek, Sharshar, David, Orlikowski, Keyvan, RAZAZI, Nicolas, DE PROST, Guillaume, CARTEAUX, Maité, GARROUSTE ORGEAS, François, Philippart, Alain, Combes, Ania, Nieszkowska, Frederic, Jacobs, Dominique, Prat, Patrick, Lafforgue, Claire, ARA SOMOHANO, Clémence, MINET, Maxime, LUGOSI, Julien, Maizel, Jean Christophe, Navellou, Bruno, Mourvillier, Lila, Bouadma, Jean François, Timsit, Claude Denis, Martin, Julien, Textoris, Sandrine, Wiramus, Clément, BRUN, Benoît, RAGONNET, Ali, Ait-Hssain, Samia, Touati, Jean, Kuba, Vincent, Willems, Pierre, Lahillaire, Mohammed, Lassi, Marion, ANTONA, Alia, MEGHENEM, Marine, DEMESMAY, Eric, Boulet, Olivier, LOUTREL, Romain, DUMONT, Antoine, ROQUILLY, Pierre-Joachim, MAHE, Dominique, DEMEURE dit LATTE, Philippe, CHAMPIN, Jean François, ARNOULD, Raphaël, CINOTTI, Ronan, Le FLOCH, Marc, Clavel, Philippe, Vignon, Nicolas, Pichon, Emmanuelle, BEGOT, Anne-Laure, FEDOU, Catherine, CHAPELLAS, Antoine, GALY, Dalila, Benzekri Lefevre, Armelle, Mathonnet, Anne, Bretagnol, Isabelle, Runge, François, BARBIER, Grégoire, MULLER, Denis, GAROT, Pierre François, DEQUIN, Dominique, PERROTIN, Annick, LEGRAS, Julie, MANKIKIAN, Patrice, TALEC, Stephan, EHRMANN, Aurélie, JORET, Claire, LHOMMET, Emmanuelle, ROUVE, Laetitia, BODET-CONTENTIN, Youenn, JOUAN, Charlotte, SALMONGANDONNIERE, Laurent, MARTIN-LEFEVRE, Matthieu, HENRY-LAGARRIGUE, Aihem, YEHIA, Jean-Baptiste, LASCARROU, Christine, LEBERT, Jean-Claude, LACHERADE, Eric, LEVESQUE, Yen-Lan, NGUYEN, Fabrice, DAVIAUD, Adrien, BOUGLE, Jean Paul, MIRA, Jean Daniel, CHICHE, Frederic, PENE, Tristan, MORICHAU-BEAUCHANT, Guillaume, GERI, Pierre Henri, DESSALLES, Yannick, MONSEAU, Mélanie, SAINT-LEGER, Sandrine, BEDON-CARTE, Laetitia, Bodet-Contentin, Walid, Darwiche, Stephan, Ehrmann, Denis, Garot, Antoine, Guillon, Youenn, Jouan, Annick, Legras, Julie, Mankikian, Emmanuelle, Mercier, Marlene, Morisseau, Yonatan, Perez, Emmanuelle, Rouve, Charlotte, Salmon-Gandonniere, Julie, Helms, Hassene, Rahmani, Alexandra, Monnier, Hamid, Merdji, Raphael, Clere-Jehl, Laure, Stiel, Antoine, Studer, Pascal, Andreu, Jean-Baptiste, Roudaut, Marie, Labruyere, Marine, Jacquier, Francois, Barbier, Dalila, Benzekri, Thierry, Boulain, Sophie, Jacquier, Gregoire, Muller, Mai-Anh, Nai, Sophie, Tollec, Damien, Roux, Jonathan, Messika, Constance, Vuillard, Louis-Marie, Dumont, Laura, Federici, Noemie, Zucman, Marc, Amouretti, Djillali, Annane, Pierre, Moine, Paris, Meng, Rania, Bounab, Muriel-Sarah, Fartoukh, Michel, Djibre, Alexandre, Elabbadi, Marie-Ange, Azais, Konstantinos, Bachoumas, Arthur, Bailly, Remi, Bernardon, Gauthier, Blonz, Luc, Desmedt, Brian, Emonet, Maud, Fiancette, Matthieu, Henry, Jean-Claude, Lacherade, Jean-Baptiste, Lascarrou, Christine, Lebert, Julien, Lorber, Laurent Martin-, Lefevre, Caroline, Pouplet, Isabelle, Vinatier, Aihem, Yehia, Sarah, Benghanem, Julien, Charpentier, Clara, Vigneron, Anne-Laure, Fedou, Claire, Mancia, Emmanuelle, Begot, Thomas, Daix, Antoine, Galy, Celine, Gonzalez, Marine, Goudelin, Bruno, Evrard, Arnaud, Desachy, Julien, Vaidie, Guillaume, Gilbert, Cedric, Darreau, Benoit, Derrien, Marjorie, Saint-Martin, Patrice, Tirot, Mickael, Landais, Nicolas, Chudeau, Jean Christophe, Callahan, Dominique, Vivier, Charlene, Le Moal, Pierre-Yves, Olivier, Remy, Marnai, Francis, Schneider, Nicolas, Sedillot, Xavier, Tchenio, Adrien, Robine, Yves, Poncelin, Remi, Bruyere, Heming, Nicholas, Renault, Alain, Kuperminc, Emmanuelle, Brun-Buisson, Christian, Megarbane, Bruno, Quenot, Jean-Pierre, Siami, Shidasp, Cariou, Alain, Forceville, Xavier, Schwebel, Carole, Leone, Marc, Timsit, Jean-Francois, Misset, Benoît, Benali, Mohamed Ali, Colin, Gwenhael, Souweine, Bertrand, Asehnoune, Karim, Mercier, Emmanuelle, Chimot, Loïc, Charpentier, Claire, François, Bruno, Boulain, Thierry, Petitpas, Frank, Constantin, Jean Michel, Dhonneur, Gilles, Baudin, François, Combes, Alain, Bohé, Julien, Loriferne, Jean-François, Cook, Fabrice, Slama, Michel, Leroy, Olivier, Capellier, Gilles, Dargent, Auguste, Hissem, Tarik, Bounab, Rania, Maxime, Virginie, Moine, Pierre, Bellissant, Eric, and Annane, Djillali

Published
2024
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5. The 16S rRNA lung microbiome in mechanically ventilated patients: a methodological study

Author

Melanie Fromentin, Antoine Bridier-Nahmias, Jérôme Legoff, Severine Mercier-Delarue, Noémie Ranger, Constance Vuillard, Julien Do Vale, Noémie Zucman, Antonio Alberdi, Jean-Damien Ricard, and Damien Roux

Subjects
Pulmonary and Respiratory Medicine, Bacteria, Microbiota, RNA, Ribosomal, 16S, Clinical Biochemistry, High-Throughput Nucleotide Sequencing, Humans, Lung, Respiration, Artificial, Molecular Biology
Abstract

Characterization of the respiratory tract bacterial microbiome is in its infancy when compared to the gut microbiota. To limit bias mandates a robust methodology. Specific amplification of the hypervariable (V) region of the 16SrRNA gene is a crucial step. Differences in accuracy exist for one V region to another depending on the sampled environment. We aimed to assess the impact of the primer sequences targeting the V4 region currently used for gut microbiota studies in respiratory samples.

Published
2021

6. Comparison of standard prophylactic, intermediate prophylactic and therapeutic anticoagulation in patients with severe COVID-19: protocol for the ANTICOVID multicentre, parallel-group, open-label, randomised controlled trial

Author

Vincent Labbe, Damien Contou, Nicholas Heming, Bruno Megarbane, Hafid Ait-Oufella, Florence Boissier, Serge Carreira, Alexandre Robert, Emmanuel Vivier, Mohamed Fejjal, Denis Doyen, Mehran Monchi, Sebastien Preau, Elise Noel-Savina, Bertrand Souweine, Noémie Zucman, Santiago Alberto Picos, Martin Dres, William Juguet, Eric Mariotte, Jean-François Timsit, Matthieu Turpin, Keyvan Razazi, Ségolène Gendreau, Samia Baloul, Guillaume Voiriot, Muriel Fartoukh, Etienne Audureau, Armand Mekontso Dessap, CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Groupe de recherche clinique CARMAS (Cardiovascular and Respiratory Manifestations of Acute lung injury and Sepsis) (CARMAS), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-CHU Henri Mondor [Créteil], Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre Hospitalier Victor Dupouy, Hôpital Raymond Poincaré [Garches], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Infection et inflammation (2I), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Lariboisière-Fernand-Widal [APHP], Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S_1144 / U1144)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), CHU Saint-Antoine [AP-HP], Sorbonne Université (SU), 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), Centre Hospitalier de Saint-Camille [Bry sur Marne], Centre Hospitalier Simone Veil (CH Simone Veil), Centre méditerranéen de médecine moléculaire (C3M), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA), Centre hospitalier Saint Joseph - Saint Luc [Lyon], Centre Hospitalier Léon Binet, Hôpital l'Archet, Unité de Recherche Clinique de la Côte d’Azur (URRIS UR2CA), Centre Hospitalier Universitaire de Nice (CHU Nice)-Université Côte d'Azur (UCA), Centre Hospitalier de Melun (CHM), Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 (RID-AGE), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Lille, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Hôpital Louis Mourier - AP-HP [Colombes], Centre Hospitalier de la Dracénie [Draguignan], CHU Pitié-Salpêtrière [AP-HP], Hôpital Avicenne [AP-HP], Université Sorbonne Paris Nord, Hopital Saint-Louis [AP-HP] (AP-HP), AP-HP - Hôpital Bichat - Claude Bernard [Paris], 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, Groupe Henri Mondor-Albert Chenevier, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier, Département Médico-Universitaire APPROCHES, 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)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Henri Mondor [Créteil], Unité de Recherche Clinique de la Côte d’Azur [Nice] (URRIS UR2CA), Université Côte d'Azur (UCA), CHU Larrey, Site Simone Veil [CHPC], CH Centre Hospitalier Public du Cotentin (CHPC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Henri Mondor, Hôpital Raymond Poincaré [AP-HP], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC), Centre Hospitalier de Cannes, Centre Hospitalier Universitaire de Nice (CHU Nice), Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, Département Médico-Universitaire Épidémiologie et biostatistique, Santé publique, Pharmacie, Pharmacologie, Recherche, Information médicale, Thérapeutique et médicaments) (DMU Esprit), CHU Charles Foix [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [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)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Université Paris Cité - UFR Médecine Paris Nord [Santé] (UPC Médecine Paris Nord), Université Paris Cité (UPC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Université Sorbonne Paris Nord, UFR Médecine [Santé] - Université Paris Cité (UFR Médecine UPCité), Université Paris Cité (UPCité), 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 Henri Mondor, Balse, Elise, 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 Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], 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], and Université Paris Cité - UFR Médecine [Santé] (UPCité UFR Médecine)

Subjects
Microcirculation, [SDV]Life Sciences [q-bio], Anticoagulants, COVID-19, Respiratory infections, General Medicine, [SDV] Life Sciences [q-bio], Anticoagulation, Thromboembolism, Quality of Life, Humans, Multicenter Studies as Topic, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Blood Coagulation, Randomized Controlled Trials as Topic
Abstract

IntroductionCOVID-19 induces venous, arterial and microvascular thrombosis, involving several pathophysiological processes. In patients with severe COVID-19 without macrovascular thrombosis, escalating into high-dose prophylactic anticoagulation (HD-PA) or therapeutic anticoagulation (TA) could be beneficial in limiting the extension of microvascular thrombosis and forestalling the evolution of lung and multiorgan microcirculatory dysfunction. In the absence of data from randomised trials, clinical practice varies widely.Methods and analysisThis is a French multicentre, parallel-group, open-label, randomised controlled superiority trial to compare the efficacy and safety of three anticoagulation strategies in patients with COVID-19. Patients with oxygen-treated COVID-19 showing no pulmonary artery thrombosis on computed tomography with pulmonary angiogram will be randomised to receive either low-dose PA, HD-PA or TA for 14 days. Patients attaining the extremes of weight and those with severe renal failure will not be included. We will recruit 353 patients. Patients will be randomised on a 1:1:1 basis, and stratified by centre, use of invasive mechanical ventilation, D-dimer levels and body mass index. The primary endpoint is a hierarchical criterion at day 28 including all-cause mortality, followed by the time to clinical improvement defined as the time from randomisation to an improvement of at least two points on the ordinal clinical scale. Secondary outcomes include thrombotic and major bleeding events at day 28, individual components of the primary endpoint, number of oxygen-free, ventilator-free and vasopressor-free days at day 28, D-dimer and sepsis-induced coagulopathy score at day 7, intensive care unit and hospital stay at day 28 and day 90, and all-cause death and quality of life at day 90.Ethics and disseminationThe study has been approved by an ethical committee (Ethics Committee, Ile de France VII, Paris, France; reference 2020-A03531-38). Patients will be included after obtaining their signed informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04808882.

Published
2022

8. The consequences of COVID-19 pandemic on patients with monoclonal gammopathy-associated systemic capillary leak syndrome (Clarkson disease)

Author

Marc Pineton de Chambrun, Quentin Moyon, Stanislas Faguer, Geoffrey Urbanski, Alexis Mathian, Noémie Zucman, Marie Werner, Charles-Edouard Luyt, Franco Verlicchi, Zahir Amoura, Marie Gousseff, Wladimir Mauhin, Arnaud Hot, Jean-Christophe Lega, Marc Lambert, Sophie Riviere, Antoine Dossier, Marc Ruivard, François Lhote, Gilles Blaison, Sybille Merceron, Nathalie Zapella, Laurent Alric, Christian Agard, Mathieu Lacout, David Saadoun, Julie Graveleau, Martin Soubrier, Julien Haroche, Julien Boileau, Marie-Josee Lucchini-Lecomte, Thomas Hanslik, Christine Christides, Hervé Levesque, Aline Talasczka, Caroline Bulte, Eric Hachulla, Olivier Decaux, Romain Sonneville, Florent Ibouanga, Bertrand Arnulf, Marcel Benedit, Jean François Viallard, Nathalie Tieulie, Fadi Haddad, Bruno Moulin, Fleur Cohen-Aubert, Pierre-Yves Lovey, Sylvie le Moal, Béatrice Bibes, Georges-Etienne Rivard, Eric Rondeau, Giuseppe Malizia, Philippe Debourdeau, Pierre Abgueguen, Annick Bosseray, Jérôme Devaquet, Claire Presne, François Liferman, Nicolas Limal, Laurent Argaud, Romain Hernu, Sylvie de la Salle, Jorge Álvarez Troncoso, John Harty, Pascal Godmer, Miguel Hie, Thomas Papo, and Pierre-Yves Hatron

Subjects
SARS-CoV-2, systemic capillary-leak syndrome, Paraproteinemias, Immunology and Allergy, COVID-19, Humans, Clinical Communications, Clarkson’s disease, vaccination, Pandemics, Capillary Leak Syndrome
Published
2021

9. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial

Author

Stephan Ehrmann, Jie Li, Miguel Ibarra-Estrada, Yonatan Perez, Ivan Pavlov, Bairbre McNicholas, Oriol Roca, Sara Mirza, David Vines, Roxana Garcia-Salcido, Guadalupe Aguirre-Avalos, Matthew W Trump, Mai-Anh Nay, Jean Dellamonica, Saad Nseir, Idrees Mogri, David Cosgrave, Dev Jayaraman, Joan R Masclans, John G Laffey, Elsa Tavernier, Ahmad A Elshafei, Brady J Scott, Tyler Weiss, Ramandeep Kaur, Lauren J Harnois, Amanda Miller, Flor Cerda, Andrew Klein, Jacob R Burd, Kathleen Posa-Kearney, Matthew Trump, Julie Jackson, Trevor Oetting, Mark Greenwood, Lindsay Hazel, Lisa Kingery, Lindsey Morris, Joon Yong Moon, Julianne Garnett, Shijing Jia, Kristine Nelson, Camilla Giacomini, John Laffey, Aoife Brennan, Conor Judge, Maeve Kernan, Claire Kelly, Ritika Ranjan, Siobhan Casey, Kevin O'Connell, Evelyn Newell, David Gallagher, Alistair Nichol, Ger Curley, Miguel Ibarra Estrada, Roxana García-Salcido, Alexandra Vargas-Obieta, Sara A Aguirre-Díaz, Luz Alcántar-Vallín, Montserrat Alvarado-Padilla, Quetzalcóatl Chávez-Peña, José A López-Pulgarín, Julio C Mijangos-Méndez, Miguel Marín-Rosales, Jorge E García-Alvarado, Oscar G Baltazar-González, Maura C González-Guerrero, Paola G Gutiérrez Ramírez, Sean Gilman, Patrice Plamondon, Rachel Roy, Jason Shahin, Raham Ragoshai, Aasmine Kaur, Josie Campisi, Joseph Dahine, Stefanie Perron, Slimane Achouri, Ronald Racette, Anne Kulenkamp, Andrés Pacheco, Marina García-de-Acilu, Irene Dot, Laetitia Bodet-Contentin, Denis Garot, Emmanuelle Mercier, Charlotte Salmon Gandonnière, Marlène Morisseau, Youenn Jouan, Walid Darwiche, Annick Legras, Antoine Guillon, Pierre-François Dequin, Anne-Charlotte Tellier, Jean Reignier, Jean-Baptiste Lascarrou, Amélie Seguin, Luc Desmedt, Emmanuel Canet, Christophe Guitton, Rémy Marnai, Jean-Christophe Callahan, Mickaël Landais, Nicolas Chudeau, Cédric Darreau, Patrice Tirot, Marjorie Saint Martin, Charlene Le Moal, Grégoire Muller, Sophie Jacquier, Gwenaël Prat, Pierre Bailly, Nicola Ferrière, Arnaud W Thille, Jean-Pierre Frat, Clément Saccheri, Matthieu Buscot, Gaëtan Plantefève, Damien Contou, Damien Roux, Jean-Damien Ricard, Laura Federici, Noémie Zucman, Santiago Freita Ramos, Marc Amouretti, Sébastien Besset, Coralie Gernez, Agathe Delbove, Guillaume Voiriot, Alexandre Elabbadi, Muriel Fartoukh, Sébastien Préau, Raphaël Favory, Alexandre Pierre, Arnaud Sement, Nicolas Terzi, Florian Sigaud, Clara Candille, Emanuele Turbil, Julien Maizel, Clément Brault, Yoan Zerbib, Aurélie Joret, Cédric Daubin, Laurent Lefebvre, Alais Giraud, Adrien Auvet, Christophe Vinsonneau, Mehdi Marzouk, Jean-Pierre Quenot, Pascal Andreu, Marie Labruyère, Jean-Baptiste Roudaut, François Aptel, Alexandre Boyer, Philippe Boyer, Jean-Claude Lacherade, Hugo Hille, Marie Bouteloup, Matthieu Jeannot, Marc Feller, Guillaume Grillet, Bruno Levy, Antoine Kimmoun, Service de Médecine Intensive Réanimation [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d'Etude des Pathologies Respiratoires (CEPR), UMR 1100. Equipe 3 'Aérosolthérapie et biothérapies à visée respiratoire' (CEPR. Equipe 3), Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Adult, Pulmonary and Respiratory Medicine, Canada, medicine.medical_specialty, medicine.medical_treatment, medicine.disease_cause, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Patient Positioning, 03 medical and health sciences, 0302 clinical medicine, Correspondence, Prone Position, medicine, Humans, Intubation, Prospective Studies, 030212 general & internal medicine, Wakefulness, Mexico, ComputingMilieux_MISCELLANEOUS, SARS-CoV-2, business.industry, Incidence (epidemiology), Hazard ratio, COVID-19, United States, 3. Good health, Prone position, Treatment Outcome, 030228 respiratory system, Respiratory failure, Spain, Relative risk, Emergency medicine, Observational study, France, Respiratory Insufficiency, business, Ireland, Nasal cannula
Abstract

Summary Background Awake prone positioning has been reported to improve oxygenation for patients with COVID-19 in retrospective and observational studies, but whether it improves patient-centred outcomes is unknown. We aimed to evaluate the efficacy of awake prone positioning to prevent intubation or death in patients with severe COVID-19 in a large-scale randomised trial. Methods In this prospective, a priori set up and defined, collaborative meta-trial of six randomised controlled open-label superiority trials, adults who required respiratory support with high-flow nasal cannula for acute hypoxaemic respiratory failure due to COVID-19 were randomly assigned to awake prone positioning or standard care. Hospitals from six countries were involved: Canada, France, Ireland, Mexico, USA, Spain. Patients or their care providers were not masked to allocated treatment. The primary composite outcome was treatment failure, defined as the proportion of patients intubated or dying within 28 days of enrolment. The six trials are registered with ClinicalTrials.gov , NCT04325906 , NCT04347941 , NCT04358939 , NCT04395144 , NCT04391140 , and NCT04477655 . Findings Between April 2, 2020 and Jan 26, 2021, 1126 patients were enrolled and randomly assigned to awake prone positioning (n=567) or standard care (n=559). 1121 patients (excluding five who withdrew from the study) were included in the intention-to-treat analysis. Treatment failure occurred in 223 (40%) of 564 patients assigned to awake prone positioning and in 257 (46%) of 557 patients assigned to standard care (relative risk 0·86 [95% CI 0·75−0·98]). The hazard ratio (HR) for intubation was 0·75 (0·62−0·91), and the HR for mortality was 0·87 (0·68−1·11) with awake prone positioning compared with standard care within 28 days of enrolment. The incidence of prespecified adverse events was low and similar in both groups. Interpretation Awake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. These results support routine awake prone positioning of patients with COVID-19 who require support with high-flow nasal cannula. Funding Open AI inc, Rice Foundation, Projet Hospitalier de Recherche Clinique Interregional, Appel d'Offre 2020, Groupement Interregional de Recherche Clinique et d'Innovation Grand Ouest, Association pour la Promotion a Tours de la Reanimation Medicale, Fond de dotation du CHRU de Tours, Fisher & Paykel Healthcare Ltd.

Published
2021

10. Extracorporeal membrane oxygenation network organisation and clinical outcomes during the COVID-19 pandemic in Greater Paris, France: a multicentre cohort study

Author

Guillaume Lebreton, Matthieu Schmidt, Maharajah Ponnaiah, Thierry Folliguet, Marylou Para, Julien Guihaire, Emmanuel Lansac, Edouard Sage, Bernard Cholley, Bruno Mégarbane, Pierrick Cronier, Jonathan Zarka, Daniel Da Silva, Sebastien Besset, Tristan Morichau-Beauchant, Igor Lacombat, Nicolas Mongardon, Christian Richard, Jacques Duranteau, Charles Cerf, Gabriel Saiydoun, Romain Sonneville, Jean-Daniel Chiche, Patrick Nataf, Dan Longrois, Alain Combes, Pascal Leprince, Charles JUVIN, Thibault SCHOELL, Cosimo D'Alessandro, Sofica MARIN, Nathalie NARDONE, Pierre DEMONDION, Horacio MEYER, Karl BOUNADER, Alexander MOIROUX, Ali AKAMKAM, Guillaume FADEL, Erwan RANDRIANALISOA, Sébastien CUSQUEL, Patrice LE GLOAHEC, Elisabeth HIRSCHAUER, Fabrice MUSQUET, Pierre-Marie Jego, Hélène Guedes, Théophile Roy, Lina Mercereau, Emmanuel Corvol, Anne Laboure, Flore Vilanove, Marco Peperoni, Dariène Machado, Aly Sely, Marion Fortanier, Séverine Gantois, Emilie Tran, Elisabeth Bosq, Aurélie Fontanier, Alice Morin, Jocelyne Cousin, Stéphanie Bovagnet, Charles Edouard Luyt, Guillaume Hekimian, Nicolas Brechot, Marc Pineton de Chambrun, Cyrielle Desnos, Juliette Chomeloux, Jeremy Arzoine, Emmanuelle Guerin, Antoine Monsel, Guillaume Voiriot, David Levy, Elodie Baron, Alexandra Beurton, Juliette Chommeloux, Meng Paris, Safaa Nemlaghi, Pierre Bay, Alexandre Demoule, Bertrand Guidet, Jean Michel Constantin, Muriel Fartoukh, Martin Dres, Guillaume Franchineau, Lucie Le Fevre, Richard Raffoul, Soleiman Alkhoder, Walid Ghodbane, Angelo Pisani, Wael Braham, Ali Bessem Gara, Pierre MORDANT, Yves-Hervé CASTIER, Etienne de MONTMOLLIN, Lila BOUADMA, Jean-François TIMSIT, Olivier Langeron, Quentin de Roux, Claire Alessandri, Margot Arminot-Frémaux, Simon Clariot, Thomas Dessalle, Agathe Kudela, André Ly, Arnaud Meffert, Elena Skripkina, Antonio Fiore, Costin Radu, Eleonora Dupuy-Montbrun, Christian Latremouille, Olaf Mercier, Philippe Deleuze, François STEPHAN, Marie Werner, Jean-Louis Teboul, Xavier Monnet, Hassan Debbagh, Alain Chapelier, Julien De Wolf, Matthieu Glorion, Ciprian Pricopi, Francesco Cassiano, Sébastien Jacquemin, Guillaume Tachon, François Parquin, Benjamin Zuber, Alain Carriou, Jean-Paul Mira, Julien Charpentier, Frederic Pene, Lee Nguyen, Sébastian Voicu, Nicolas Deye, Isabelle Malissin, Laetitia Sutterlin, Giulia Naim, Adrien Pépin-Lehalleur, Aymen Mrad, Jean-Michel Ekhérian, Philippe Nguyen, Georgios Sidéris, Dominique Vodovar, Caroline Grant, Mattéo Arcelli, Alban Copie, Zaccaria Errabih, Antoine Gonde, Adèle Magalhaes, Edouard Meurisse, Kiyoko Nitenberg, Arthur Perault, Lucile Perrin, Maxime Renaux, Sophie Marqué, Luis Ensenyat-Martin, Eric Delpierre, Matthieu Duprey, Daniel da Silva, Bruno Verdière, Julien Amour, Marina Clément, Yves Ollivier, Fabrice Daviaud, Camille Le Breton, Santiago Freita-Ramos, Marc Amouretti, Pierre Antoine Billiet, Myriam Dao, Louis Marie Dumont, Laura Federici, Baptiste Gaborieau, Pierre Postel-Vinay, Constance Vuillard, Noémie Zucman, Didier Dreyfuss, Jean Damien Ricard, Damien Roux, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases [IHU 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), CHU Pitié-Salpêtrière [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 Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), 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, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Marie-Lannelongue, Institut Mutualiste de Montsouris (IMM), Hôpital Foch [Suresnes], 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), Service de Réanimation Médicale et Toxicologique [Hôpital Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], 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 Sud Francilien, Centre hospitalier est francilien, Hôpital Delafontaine, Centre Hospitalier de Saint-Denis [Ile-de-France], Hôpital Louis Mourier - AP-HP [Colombes], Centre cardiologique du Nord (CCN), Hôpital Privé Jacques Cartier [Massy], AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Hôpital Cochin [AP-HP], Paris ECMO-COVID-19 investigators, Mégarbane, Bruno, and Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN)

Subjects
Male, ARDS, medicine.medical_treatment, Corrections, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Cohort Studies, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Fraction of inspired oxygen, score, support: volume, Renal Insufficiency, 030212 general & internal medicine, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Respiratory Distress Syndrome, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, ecmo covid-19, Articles, Middle Aged, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Pulmonary embolism, [SDV.TOX] Life Sciences [q-bio]/Toxicology, Intensive Care Units, Outcome and Process Assessment, Health Care, surgical procedures, operative, [SDV.TOX]Life Sciences [q-bio]/Toxicology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, France, Cohort study, Pulmonary and Respiratory Medicine, medicine.medical_specialty, 03 medical and health sciences, Extracorporeal Membrane Oxygenation, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Intensive care, medicine, Extracorporeal membrane oxygenation, Humans, Renal replacement therapy, SARS-CoV-2, Septic shock, business.industry, COVID-19, medicine.disease, Survival Analysis, 030228 respiratory system, Emergency medicine, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Pulmonary Embolism, business
Abstract

Erratum inCorrection to Lancet Respir Med 2021; published online April 19. https://doi.org/10.1016/S2213-2600(21)00096-5.; International audience; Background: In the Île-de-France region (henceforth termed Greater Paris), extracorporeal membrane oxygenation (ECMO) for severe acute respiratory distress syndrome (ARDS) was considered early in the COVID-19 pandemic. We report ECMO network organisation and outcomes during the first wave of the pandemic.Methods: In this multicentre cohort study, we present an analysis of all adult patients with laboratory-confirmed SARS-CoV-2 infection and severe ARDS requiring ECMO who were admitted to 17 Greater Paris intensive care units between March 8 and June 3, 2020. Central regulation for ECMO indications and pooling of resources were organised for the Greater Paris intensive care units, with six mobile ECMO teams available for the region. Details of complications (including ECMO-related complications, renal replacement therapy, and pulmonary embolism), clinical outcomes, survival status at 90 days after ECMO initiation, and causes of death are reported. Multivariable analysis was used to identify pre-ECMO variables independently associated with 90-day survival after ECMO.Findings: The 302 patients included who underwent ECMO had a median age of 52 years (IQR 45-58) and Simplified Acute Physiology Score-II of 40 (31-56), and 235 (78%) of whom were men. 165 (55%) were transferred after cannulation by a mobile ECMO team. Before ECMO, 285 (94%) patients were prone positioned, median driving pressure was 18 cm H2O (14-21), and median ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen was 61 mm Hg (IQR 54-70). During ECMO, 115 (43%) of 270 patients had a major bleeding event, 27 of whom had intracranial haemorrhage; 130 (43%) of 301 patients received renal replacement therapy; and 53 (18%) of 294 had a pulmonary embolism. 138 (46%) patients were alive 90 days after ECMO. The most common causes of death were multiorgan failure (53 [18%] patients) and septic shock (47 [16%] patients). Shorter time between intubation and ECMO (odds ratio 0·91 [95% CI 0·84-0·99] per day decrease), younger age (2·89 [1·41-5·93] for ≤48 years and 2·01 [1·01-3·99] for 49-56 years vs ≥57 years), lower pre-ECMO renal component of the Sequential Organ Failure Assessment score (0·67, 0·55-0·83 per point increase), and treatment in centres managing at least 30 venovenous ECMO cases annually (2·98 [1·46-6·04]) were independently associated with improved 90-day survival. There was no significant difference in survival between patients who had mobile and on-site ECMO initiation.Interpretation: Beyond associations with similar factors to those reported on ECMO for non-COVID-19 ARDS, 90-day survival among ECMO-assisted patients with COVID-19 was strongly associated with a centre's experience in venovenous ECMO during the previous year. Early ECMO management in centres with a high venovenous ECMO case volume should be advocated, by applying centralisation and regulation of ECMO indications, which should also help to prevent a shortage of resources.

Published
2021

11. Cold agglutinin disease secondary to severe SARS-CoV-2 treated with eculizumab

Author

Yachar, Dawudi, Laura, Federici, Jérôme, Debus, and Noémie, Zucman

Subjects
SARS-CoV-2, COVID-19, Humans, Anemia, Hemolytic, Autoimmune, General Medicine, Antibodies, Monoclonal, Humanized
Abstract

Impaired immune response with uncontrolled inflammation and various immunological disorders have been reported during SARS-CoV-2 infection. Here, we report a case of cold agglutinin disease occurring during a severe coronavirus disease 2019 (COVID-19) in a French intensive care unit. A patient was presented with acute respiratory distress syndrome, acute renal failure and haemolytic anaemia. Direct antiglobulin test was positive with a cold agglutinin titre of 1/512. No other cause than COVID-19 explained the occurrence of cold agglutinin disease; however, causality could not be formally established. Persistent anaemia despite transfusion therapy and the short-term life-threatening, prompted the infusion of a monoclonal anti-C5 antibody (eculizumab). Eculizumab therapy quasi-fully resolved haemolysis within a few days, but ultimately the patient died from his severe COVID-19 infection. Data regarding the specific treatment of cold agglutinin disease during COVID-19 are rare. Although additional studies are warranted, eculizumab may be considered in critical situations.

Published
2022

12. Extracorporeal membrane oxygenation for refractory COVID-19 acute respiratory distress syndrome

Author

B. Gaborieau, Noémie Zucman, M. Amouretti, Alain Combes, Didier Dreyfuss, P.A. Billiet, L.M. Dumont, P. Postel-Vinay, Guillaume Lebreton, S. Freita-Ramos, Jean-Damien Ricard, D. Longrois, Damien Roux, C. Le Breton, M. Dao, S. Besset, L. Federici, C. Vuillard, Des Maladies Rénales Rares aux Maladies Fréquentes, Remodelage et Réparation, Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Université de Paris (UP), Université de Paris - UFR Médecine Paris Nord [Santé] (UP Médecine Paris Nord), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, 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], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)

Subjects
2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Extracorporeal membrane oxygenation, Acute respiratory distress syndrome, business.industry, medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), [SDV]Life Sciences [q-bio], COVID-19, Acute respiratory distress, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, Article, 03 medical and health sciences, 0302 clinical medicine, Refractory, Anesthesia, medicine, 030212 general & internal medicine, business
Published
2020
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13. 16s rRNA Lung Microbiota Study in Mechanically Ventilated Patient: A Pilot Study

Author

Constance Vuillard, Jean-Damien Ricard, Antonio Alberdi, Julien Dovale, Antoine Bridier-Nahmias, Jérôme LeGoff, Noémie Zucman, Noémie Ranger, Damien Roux, Mélanie Fromentin, and Séverine Mercier-Delarue

Subjects
Lung, medicine.anatomical_structure, Text mining, business.industry, medicine, Biology, 16S ribosomal RNA, business, Microbiology
Abstract

BackgroundCharacterization of the respiratory tract bacterial microbiota is in its infancy when compared to the gut microbiota knowledge. As key methodological steps can directly affect the accuracy of the results, it is crucial to determine a robust methodology in order to limit bias.Two different pairs of primers 515F-806R targeting the V4 hypervariable region of the 16SrRNA gene, “S-V4” for “Stringent V4” primer pair and “R-V4” for “Relaxed V4” primer pair, are respectively used in two ongoing international projects “the Human microbiome project” and “the Earth microbiome project”. We compared two methods of sample processing using these two different primer pairs for bacterial microbiota analyses of respiratory samples from critically-ill ventilated patients. For the later, Illumina 250 paired-end sequencing was done on a MiSeq platform after DNA extraction using mechanical lysis (bead-beating) and NucliSENS easyMAG. The concordance with conventional microbiology is the criterion of choice to determine the optimal method.ResultsTwenty samples from seven patients and four controls were sequenced. The two primer pair provided highly different results. Only 54% of the samples had a similar microbial composition with both pairs of primers. “S-V4” gave the best agreement with the conventional microbiology for ETA: 89% as compared to 44% for the “R-V4” primer pair. The main difference related to Enterobacteriaceae, which were concordant between conventional cultures and microbiota analyses using “S-V4”. Enterobacteriaceae detection was poor for “R-V4”. Among patients with VAP, a decrease in alpha diversity in ETA was observed. The mean of pairwise Unifrac distance was higher inside this group of patients at the time of VAP diagnosis as compared to control patients.ConclusionAccuracy of the bacterial lung microbiota composition was highly correlated to the pair of primers used for amplification of the 16s rRNA hypervariable sequence. Comparison of microbiota results obtained by sequencing and conventional microbiology allowed us to select the best option for further studies. This work validates our methodology based on 16SrRNA gene amplification with 515F-806R “S-V4” primer pair associated to Illumina® MiSeq 250 paired-end sequencing.

Published
2020

14. Severe Reinfection With South African Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Variant 501Y.V2

Author

Noémie Zucman, Damien Roux, Diane Descamps, Jean-Damien Ricard, Fabrice Uhel, and Center of Experimental and Molecular Medicine

Subjects
Microbiology (medical), 2019-20 coronavirus outbreak, Infectious Diseases, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Medicine, business, Virology
Published
2021

15. Clinical significance of upper airway virus detection in critically ill hematology patients

Author

Matthieu Resche-Rigon, Anne-Pascale Meert, Séverine Mercier-Delarue, Alexandre Demoule, Pierre Perez, Fabrice Bruneel, Adrien Contejean, Jérôme LeGoff, Noémie Zucman, Jérôme Lambert, Frédéric Pène, Michael Darmon, Antoine Rabbat, Dominique Benoit, Virginie Lemiale, Christine Lebert, François Vincent, Carole Schwebel, Achille Kouatchet, Mercé Jourdain, Martine Nyunga, Djamel Mokart, Elie Azoulay, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Unité de Soins Intensifs [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Service de biostatistiques et information médicale [Saint-Louis], Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Pitié-Salpêtrière [APHP], Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Institut Jules Bordet, Ghent University Hospital, Centre Hospitalier Universitaire [Grenoble] (CHU), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), and Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)

Subjects
Male, INFLUENZA-VIRUS, ADULT RECIPIENTS, Soins intensifs réanimation, OSELTAMIVIR TREATMENT, medicine.medical_treatment, Respiratory virus, Critical Care and Intensive Care Medicine, 0302 clinical medicine, Mechanical ventilation, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Medicine and Health Sciences, Medicine, 030212 general & internal medicine, Hospital Mortality, Respiratory Tract Infections, Hematology, Paramyxoviridae Infections, hematology, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Middle Aged, Diagnostic strategy, 3. Good health, respiratory virus, Intensive Care Units, Female, Pneumologie, influenza, Pulmonary and Respiratory Medicine, medicine.medical_specialty, POLYMERASE-CHAIN-REACTION, Critical Illness, Respiratory Syncytial Virus Infections, mechanical ventilation, 03 medical and health sciences, Immunocompromised Host, IMMUNOCOMPROMISED PATIENTS, Internal medicine, Influenza, Human, ACUTE RESPIRATORY-FAILURE, Humans, Clinical significance, Intensive care medicine, Aged, Picornaviridae Infections, business.industry, Critically ill, STEM-CELL TRANSPLANTATION, multiplex PCR, Multiplex PCR, Hematologic Diseases, Influenza, Virus detection, ONCOLOGY PATIENTS, 030228 respiratory system, HUMAN RHINOVIRUS, DIAGNOSTIC STRATEGY, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Airway, Multiplex Polymerase Chain Reaction
Abstract

Rationale: Noninvasive diagnostic multiplex molecular tests may enable the early identification and treatment of viral infections in critically ill immunocompromised patients. Objectives: To assess the association between viral detection in nasopharyngeal swabs and ICU mortality in critically ill hematology patients. Methods: This was a post hoc analysis of a prospective cohort of critically ill hematology patients admitted to 17 ICUs. Nasal swabs sampled and frozen at ICU admission were tested using a multiplex PCR assay. Predictors of ICU mortality and assay positivity were identified. Measurements and Main Results: Of the 747 patients (447 with acute respiratory failure [ARF]), 21.3% had a virus detected (56.4% rhinovirus/enterovirus and 30.7% influenza/ parainfluenza/respiratory syncytial viruses). Overall ICU and hospital mortality rates were 26% and 37%, respectively. Assay positivity was associated with lymphoproliferative disorders, hematopoietic stem cell transplantation, treatment with steroids or other immunosuppressants, ARF (25.5% vs. 16.3%; P = 0.004), and death in the ICU (28.9% vs. 19.3%; P = 0.008). The association with ICU mortality was significant for all viruses and was strongest for influenza/parainfluenza/respiratory syncytial viruses. In patients with ARF, detection of any respiratory virus was independently associated with ICU mortality (odds ratio, 2.07; 95% confidence interval, 1.22–3.50). Conclusions: Respiratory virus detection in the upper airway by multiplex PCR assay is common in critically ill hematology patients. In patients with ARF, respiratory virus detection was independently associated with ICU mortality. Multiplex PCR assay may prove helpful for the risk stratification of hematology patients with ARF. Studies to understand whether respiratory tract viruses play a causal role in outcomes are warranted., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2019

16. Critères de début et d’arrêt de l’épuration extrarénale en réanimation

Author

Noémie Zucman, Stéphane Gaudry, and Didier Dreyfuss

Subjects
Emergency Medicine, Emergency Nursing
Abstract

Les criteres d’initiation et d’arret de l’epuration extrarenale (EER) en cas d’insuffisance renale aigue font l’objet d’intenses debats. L’hyperkaliemie menacante, l’oedeme pulmonaire de surcharge generant une hypoxemie severe et les complications de l’hyper-uremie (pericardite et encephalopathie) sont les seuls criteres indiscutables d’EER en urgence. En dehors de ces situations, deux strategies peuvent se discuter : 1) une strategie d’EER precoce, qui a pour but de mieux controler les desordres metaboliques, mais qui expose a des risques tels que ceux lies aux catheters et a la circulation extracorporelle ; 2) une strategie d’attente, qui permet de minimiser ces risques. Les etudes francaises AKIKI et IDEAL-ICU ont pour objectif de demontrer quelle strategie est la meilleure.

Published
2015

17. Prone positioning in acute respiratory distress syndrome after abdominal surgery: a multicenter retrospective study

Author

Samuel Tuffet, David Hajage, Christian Laplace, Didier Payen, Bruno Costaglioli, Noémie Zucman, Simon Msika, Jacques Duranteau, Didier Dreyfuss, Marc Pocard, Anne-Claire Lukaszewicz, Stéphane Gaudry, and Jean-Damien Ricard

Subjects
Mechanical ventilation, ARDS, medicine.medical_specialty, Supine position, business.industry, medicine.medical_treatment, 030208 emergency & critical care medicine, Context (language use), Retrospective cohort study, Critical Care and Intensive Care Medicine, medicine.disease, Surgery, 03 medical and health sciences, Prone position, 0302 clinical medicine, Anesthesiology, Medicine, 030212 general & internal medicine, business, Abdominal surgery
Abstract

The recent demonstration of prone position’s strong benefit on patient survival has rendered proning a major therapeutic intervention in severe ARDS. Uncertainties remain as to whether or not ARDS patients in the postoperative period of abdominal surgery should be turned prone because of the risk of abdominal complications. Our aim was to investigate the prevalence of surgical complications between patients with and without prone position after abdominal surgery. This study was a multicenter retrospective cohort of patients with ARDS in a context of recent abdominal surgery. Primary outcome was the number of patients who had at least one surgical complication that could be induced or worsened by prone position. Secondary outcomes included effects of prone position on oxygenation. Data from the prone group were compared with those from the supine group (not having undergone at least a prone position session). Among 98 patients included, 36 (37%) had at least one prone position session. The rate of surgical complications induced or worsened by prone position did not differ between prone and supine groups [respectively, 14 (39%) vs 27 (44%); p = 0.65]. After propensity score application, there was no significant difference between the two groups (OR 0.72 [0.26–2.02], p = 0.54). Revision surgery did not differ between the groups. The first prone session significantly increased PaO2/FiO2 ratio from 95 ± 47 to 189 ± 92 mmHg, p

Published
2017

18. Décubitus ventral dans le contexte de chirurgie abdominale récente

Author

Samuel Tuffet, Anne-Claire Lukaszewicz, Didier Payen, Christian Laplace, Stéphane Gaudry, David Hajage, Didier Dreyfuss, Bruno Costaglioli, Noémie Zucman, Jean-Damien Ricard, Marc Pocard, Simon Msika, and Jacques Duranteau

Subjects
Anesthesiology and Pain Medicine
Abstract

Introduction Le decubitus ventral (DV), utilise comme strategie de recrutement alveolaire au cours du SDRA permet une amelioration de l’oxygenation et de la survie. Les urgences chirurgicales abdominales figurent parmi les etiologies extrapulmonaires du SDRA. En cas d’hypoxemie severe en postoperatoire, les reanimateurs sont confrontes a la decision de mettre ou non ces patients en DV. Nous avons cherche a connaitre les complications liees a la mise precoce en DV dans les suites d’une chirurgie abdominale. Patients et methodes Etude retrospective sur 5 ans, approuvee par le comite d’ethique de la SRLF (no 14–31), realisee dans 3 reanimations dont l’objectif etait de comparer la prevalence des complications chirurgicales potentiellement favorisees par le DV entre les patients ayant eu au moins une seance de DV et les patients n’ayant eu aucune seance de DV dans le contexte de SDRA dans les suites d’une chirurgie abdominale. Nous avons inclus des patients adultes ayant presente un SDRA dans un contexte de chirurgie abdominale recente ( Le critere de jugement principal etait le nombre de patients ayant eu au moins une complication chirurgicale potentiellement liee au DV. Cette liste a ete definie a priori : desunion de cicatrice, syndrome du compartiment abdominal, desinsertion de stomie, necrose de stomie, necrose de la cicatrice, abces de paroi, arrachage d’un systeme de drainage (drain peritoneal, drain biliaire), arrachage d’une gastrostomie ou d’une jejunostomie d’alimentation, fistule digestive, eventration. Resultats Parmi les 98 patients inclus (âge 64[± 18] ans, IGS2 53[± 17]), 79 (81 %) avaient ete operes dans un contexte d’urgence dont 41 peritonites. Trente-six patients (37 %) ont eu au moins une seance de DV (nombre de seances : 1 [1–2]) et 62 (63 %) aucune. Les patients mis en DV avaient un rapport PaO2/FiO2 minimal plus faible que ceux du groupe temoin (74[±24] vs 101[± 43] mmHg, p = 0,0005). La premiere seance de DV (duree moyenne 19 [± 10] heures) a permis une augmentation du rapport PaO2/FiO2 moyen de 95 (± 47) a 189 (± 92) mmHg (p = 0,001). Dans le groupe DV, 14 patients (39 %) ont presente au moins une complication chirurgicale contre 27 (44 %) dans le groupe temoin (p = 0,65). Apres application d’un score de propension, l’absence de difference persistait (OR 0,72 [0,26–2,02], p = 0,54). Ces complications ont eu pour consequence une reprise chirurgicale chez 2 (6 %) patients du groupe DV et 4 (6 %) du groupe temoin (p = 0,89). La mortalite en reanimation etait de 42 % dans le groupe DV et de 45 % dans le groupe temoin (p = 0,43). Discussion Ces resultats confirment l’efficacite du DV en terme d’amelioration de l’oxygenation chez des patients ayant eu une chirurgie abdominale recente sans augmentation significative du nombre de complications chirurgicales. Chez les patients presentant un SDRA dans le contexte d’une pathologie abdominale chirurgicale, la mise en DV en postoperatoire ne devrait pas etre limitee.

Published
2015

19. Prone positioning in acute respiratory distress syndrome after abdominal surgery

Author

Noémie Zucman, Didier Dreyfuss, S Msika, Jean-Damien Ricard, S Tuffet, M Pocard, Didier Payen, AC Anne-Claire, and Stéphane Gaudry

Subjects
medicine.medical_specialty, ARDS, business.industry, Acute respiratory distress, medicine.disease, Critical Care and Intensive Care Medicine, Prone position, Severe hypoxemia, mental disorders, Emergency medicine, Poster Presentation, medicine, Etiology, Intensive care medicine, business, Abdominal surgery
Abstract

Prone positioning has been used for many years as an alveolar recruitment strategy in acute respiratory distress syndrome (ARDS). Prone positioning in ARDS improves oxygenation and demonstrated recently its effectiveness on prognosis. Extrapulmonary etiologies of ARDS include abdominal emergencies. In cases of severe hypoxemia in the early postoperative period, intensivists discuss prone positioning based on the risk/benefit ratio.

Published
2015

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