作者
Bruno Lévy,Nicolas Girerd,Julien Amour,Emmanuel Besnier,Nicolas Nesseler,Julie Helms,Clément Delmas,Romain Sonneville,C. Guidon,Bertrand Rozec,Hélène David,David Bougon,Oussama Chaouch,Walid Oulehri,Hervé Dupont,Nicolas Belin,Lucie Gaide‐Chevronnay,Patrick Rossignol,Antoine Kimmoun,Kévin Duarte,Arthur S. Slutsky,Daniel Brodie,Jean-Luc Fellahi,Alexandre Ouattara,Alain Combes,Mathieu Mattèi,Carine Thivillier,Thomas Auchet,P. Piera Pérez,Caroline Fritz,Pablo Maureira,Maxime Hubert,Yihua Liu,Ferhat Meziani,Hamid Merdji,Alexandra Monnier,Raphaël Clère-Jehl,Ania Nieszkowska,Marc Pineton,Juliette Chommeloux,Guillaume Hékimian,Guillaume Lebreton,Astrid Quessard,Julien Imbault,Alain Rémy,Mathieu Pernot,P.-A. Joseph,Giovanni Scollo,Mattéo Pozzi,Étienne Escudier,Michel Müller,Didier Dorez,Michel Sirodot,Fabien Doguet,Vincent Scherrer,Chadi Aludaat,Michaël Bernasinski,Élie Zogheib,Thierry Caus,Philippe Bizouarn,Mickaël Vourc’h,Jean‐Christian Roussel,Thomas Sénage,Erwan Flécher,Jean‐Philippe Verhoye,Antoine Roisné,Sébastien Biedermann,Fanny Vardon‐Bounes,Laure Crognier,Jean Porterie,P Colson,Philippe Gaudard,Philippe Rouvière,Lila Bouadma,Fabrice Sinnah,Patrick Nataf,Marylou Para,Pauline Dureau,Nima Djavidi,Adrien Bouglé,Pascal Leprince,Géraldine Dessertaine,M. Durand,Pierre Albaladéjo,Cécile Martin,François Belon,Gaël Piton,Hadrien Winiszewski,Andrea Perroti,David Tonon,Bernard Cholley,Diane Zlotnik,Paul Achouh,Hélène Nougue,Olivier Collange,Paul-Michel Mertès,Michel Kindo
摘要
The optimal approach to the use of venoarterial extracorporeal membrane oxygenation (ECMO) during cardiogenic shock is uncertain.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.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.Early moderate hypothermia (33-34 °C; n = 168) for 24 hours or strict normothermia (36-37 °C; n = 166).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.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.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.ClinicalTrials.gov Identifier: NCT02754193.