Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation
Authors: Bruno Levy, Nicolas Girerd, Julien Amour, Emmanuel Besnier, Nicolas Nesseler, Julie Helms, Clément Delmas, Romain Sonneville, Catherine Guidon, Bertrand Rozec, Helène David, David Bougon, Oussama Chaouch, Oulehri Walid, Dupont Hervé, Nicolas Belin, Lucie Gaide-Chevronnay, Patrick Rossignol, Antoine Kimmoun, Kevin Duarte, Arthur S. Slutsky, Daniel Brodie, Jean-Luc Fellahi, Alexandre Ouattara, Alain Combes, Mathieu Mattei, Carine Thivillier, Thomas Auchet, Pierrre Perez, Caroline Fritz, Pablo Maureira, Maxime Hubert, Yihua Liu, Ferhat Meziani, Hamid Merdji, Alexandra Monnier, Raphaël Clere-Jehl, Ania Nieszkowska, Marc Pineton, Juliette Chommeloux, Guillaume Hékimian, Guillaume Lebreton , Astrid Quessard, Julien Imbault, Alain Rémy, Mathieu Pernot , Pierre Joseph, Giovanni Scollo, Matteo Pozzi, Étienne Escudier, Michel Muller, Didier Dorez, Michel Sirodot, Fabien Doguet, Vincent Scherrer, Chadi Aludaat, Michael Bernasinski, Elie Zogheib, Thierry Caus, Philippe Bizouarn, Mickael Vourc’h, Jean-Christian Roussel, Thomas Senage, Erwan Flecher, Jean-Philippe Verhoye, Antoine Roisne, Sébastien Biedermann, Fanny Vardon-Bounes, Laure Crognier, Jean Porterie, Pascal Colson, Philippe Gaudard, Philippe Rouviere, Lila Bouadma, Fabrice Sinnah, Patrick Nataf, Marylou Para, Pauline Dureau, Nima Djavidi, Adrien Bouglé, Pascal Leprince, Géraldine Dessertaine, Michel Durand, Pierre Albaladejo, Cecile Martin, François Belon, Gael Piton, Hadrien Winiszewski, Andrea Perroti, David Tonon, Bernard Cholley, Diane Zlotnik, Paul Achouh, Hélène Nougue, Olivier Collange, Paul Michel Mertes, Michel Kindo
Journal: JAMA (2022)

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.