Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial - Simplification des Soins chez les Patients Complexes - UR UPJV 7518 Accéder directement au contenu
Article Dans Une Revue Journal of the American Medical Association Année : 2022

Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial

1 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
2 Service de Réanimation Médicale [CHRU Nancy]
3 Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy]
4 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
5 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
6 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
7 Hôpital Privé Jacques Cartier [Massy]
8 EnVI - Endothélium, valvulopathies et insuffisance cardiaque
9 CHU Rouen
10 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
11 NuMeCan - Nutrition, Métabolismes et Cancer
12 CIC - Centre d'Investigation Clinique [Rennes]
13 Les Hôpitaux Universitaires de Strasbourg (HUS)
14 Nouvel Hôpital Civil de Strasbourg
15 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
16 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
17 CHU Marseille
18 CHU Nantes - Centre hospitalier universitaire de Nantes
19 ITX-lab - ITX-lab unité de recherche de l'institut du thorax UMR1087 UMR6291
20 PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
21 CHU Montpellier
22 Hôpital Arnaud de Villeneuve [CHRU Montpellier]
23 Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
24 HEGP - Hôpital Européen Georges Pompidou [APHP]
25 UPD5 - Université Paris Descartes - Paris 5
26 CHU Amiens-Picardie
27 Service de Réanimation médicale [CHRU Besançon]
28 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
29 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
30 Keenan Research Centre of the Li Ka Shing Knowledge Institute [Toronto]
31 University of Toronto
32 Columbia University [New York]
33 CarMeN - Cardiovasculaire, métabolisme, diabétologie et nutrition
34 Hôpital Louis Pradel [CHU - HCL]
35 Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
36 CHU Bordeaux
37 ICAN - Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases
38 Institut de cardiologie [CHU Pitié-Salpêtrière]
Catherine Guidon
  • Fonction : Auteur
Hervé Dupont
Antoine Kimmoun
  • Fonction : Auteur
  • PersonId : 782318
  • IdRef : 150592183

Résumé

IMPORTANCE: The optimal approach to the use of venoarterial extracorporeal membrane oxygenation (ECMO) during cardiogenic shock is uncertain. OBJECTIVE: To determine whether early use of moderate hypothermia (33-34 °C) compared with strict normothermia (36-37 °C) improves mortality in patients with cardiogenic shock receiving venoarterial ECMO. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of patients (who were eligible if they had been endotracheally intubated and were receiving venoarterial ECMO for cardiogenic shock for <6 hours) conducted in the intensive care units at 20 French cardiac shock care centers between October 2016 and July 2019. Of 786 eligible patients, 374 were randomized. Final follow-up occurred in November 2019. INTERVENTIONS: Early moderate hypothermia (33-34 °C; n = 168) for 24 hours or strict normothermia (36-37 °C; n = 166). MAIN OUTCOMES AND MEASURES: The primary outcome was mortality at 30 days. There were 31 secondary outcomes including mortality at days 7, 60, and 180; a composite outcome of death, heart transplant, escalation to left ventricular assist device implantation, or stroke at days 30, 60, and 180; and days without requiring a ventilator or kidney replacement therapy at days 30, 60, and 180. Adverse events included rates of severe bleeding, sepsis, and number of units of packed red blood cells transfused during venoarterial ECMO. RESULTS: Among the 374 patients who were randomized, 334 completed the trial (mean age, 58 [SD, 12] years; 24% women) and were included in the primary analysis. At 30 days, 71 patients (42%) in the moderate hypothermia group had died vs 84 patients (51%) in the normothermia group (adjusted odds ratio, 0.71 [95% CI, 0.45 to 1.13], P = .15; risk difference, -8.3% [95% CI, -16.3% to -0.3%]). For the composite outcome of death, heart transplant, escalation to left ventricular assist device implantation, or stroke at day 30, the adjusted odds ratio was 0.61 (95% CI, 0.39 to 0.96; P = .03) for the moderate hypothermia group compared with the normothermia group and the risk difference was -11.5% (95% CI, -23.2% to 0.2%). Of the 31 secondary outcomes, 30 were inconclusive. The incidence of moderate or severe bleeding was 41% in the moderate hypothermia group vs 42% in the normothermia group. The incidence of infections was 52% in both groups. The incidence of bacteremia was 20% in the moderate hypothermia group vs 30% in the normothermia group. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial involving patients with refractory cardiogenic shock treated with venoarterial ECMO, early application of moderate hypothermia for 24 hours did not significantly increase survival compared with normothermia. However, because the 95% CI was wide and included a potentially important effect size, these findings should be considered inconclusive. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02754193.
Fichier principal
Vignette du fichier
2022 Levy et al., Effect of.pdf (39.73 Mo) Télécharger le fichier
Origine : Fichiers produits par l'(les) auteur(s)

Dates et versions

hal-03594058 , version 1 (08-11-2022)

Identifiants

Citer

Bruno Levy, Nicolas Girerd, Julien Amour, Emmanuel Besnier, Nicolas Nesseler, et al.. Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial. Journal of the American Medical Association, 2022, 327 (5), pp.442-453. ⟨10.1001/jama.2021.24776⟩. ⟨hal-03594058⟩
226 Consultations
29 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More