2 results on '"Girardie, Patrick"'
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2. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial
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Lascarrou, Jean Baptiste, Meziani, Ferhat, Le Gouge, Amélie, Boulain, Thierry, Bousser, Jérôme, Belliard, Guillaume, Asfar, Pierre, Frat, Jean Pierre, Dequin, Pierre François, Gouello, Jean Paul, Delahaye, Arnaud, Hssain, Ali Ait, Chakarian, Jean Charles, Pichon, Nicolas, Desachy, Arnaud, Bellec, Fréderic, Thevenin, Didier, Quenot, Jean Pierre, Sirodot, Michel, Labadie, François, Plantefeve, Gaétan, Vivier, Dominique, Girardie, Patrick, Giraudeau, Bruno, Reignier, Jean, Care, Clinical Research, Group, Sepsis (CRICS), Group, HYPERION Study, Université de Nantes (UN), Service de Réanimation Médicale [Strasbourg], Les Hôpitaux Universitaires de Strasbourg (HUS), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg (UNISTRA), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Réanimation Polyvalente - CHR d’Orleans, Medical-Surgical Intensive Care Unit, Centre Hospitalier de Bretagne Sud, Lorient, Service de Soins Intensifs [Angers], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service de réanimation (CHRU Tours), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Service de réanimation médicale, Université Paris Diderot - Paris 7 (UPD7)-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), Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre d'Investigation Clinique de Limoges (CIC1435), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de réanimation et de surveillance continue [CH Mautauban], Centre hospitalier de Montauban, Centre Hospitalier de Lens, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], CH Argenteuil, Service de soins intensifs, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Francois Rabelais [Tours], MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Service d'anesthésie et réanimation chirurgicale [Nantes], Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-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 (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques
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Resuscitation ,medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,medicine.medical_treatment ,Hypothermia ,Targeted temperature management ,Critical Care and Intensive Care Medicine ,law.invention ,Study Protocol ,Superiority Trial ,Randomized controlled trial ,law ,Hypothermia, Induced ,Medicine ,Humans ,Therapeutic hypothermia ,Glasgow Coma Scale ,Cardiopulmonary resuscitation ,Intensive care medicine ,Adverse effect ,business.industry ,Induced ,Cardiac arrest ,Cardiopulmonary Resuscitation ,3. Good health ,Treatment Outcome ,Research Design ,Emergency Medicine ,Nonshockable rhythm ,France ,medicine.symptom ,Nervous System Diseases ,business ,Out-of-Hospital Cardiac Arrest - Abstract
International audience; BACKGROUND: Meta-analyses of nonrandomized studies have provided conflicting data on therapeutic hypothermia, or targeted temperature management (TTM), at 33° C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the International Liaison Committee on Resuscitation and by the European Resuscitation Council recommend therapeutic hypothermia. New data are available on the adverse effects of therapeutic hypothermia, notably infectious complications. The risk/benefit ratio of therapeutic hypothermia after nonshockable cardiac arrest is unclear. METHODS: HYPERION is a multicenter (22 French ICUs) trial with blinded outcome assessment in which 584 patients with successfully resuscitated nonshockable cardiac arrest are allocated at random to either TTM between 32.5 and 33.5° C (therapeutic hypothermia) or TTM between 36.5 and 37.5° C (therapeutic normothermia) for 24~hours. Both groups are managed with therapeutic normothermia for the next 24~hours. TTM is achieved using locally available equipment. The primary outcome is day-90 neurological status assessed by the Cerebral Performance Categories (CPC) Scale with dichotomization of the results (1\,+\,2 versus 3\,+\,4\,+\,5). The primary outcome is assessed by a blinded psychologist during a semi-structured telephone interview of the patient or next of kin. Secondary outcomes are day-90 mortality, hospital mortality, severe adverse events, infections, and neurocognitive performance. The planned sample size of 584 patients will enable us to detect a 9% absolute difference in day-90 neurological status with 80% power, assuming a 14% event rate in the control group and a two-sided Type 1 error rate of 4.9%. Two interim analyses will be performed, after inclusion of 200 and 400 patients, respectively. DISCUSSION: The HYPERION trial is a multicenter, randomized, controlled, assessor-blinded, superiority trial that may provide an answer to an issue of everyday relevance, namely, whether TTM is beneficial in comatose patients resuscitated after nonshockable cardiac arrest. Furthermore, it will provide new data on the tolerance and adverse events (especially infectious complications) of TTM at 32.5-33.5° C. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01994772 .
- Published
- 2015
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