Insights from patients screened but not randomised in the HYPERION trial

Annals of Intensive Care

Pierre Asfar¹  Gwenhael Colin²  Stéphane Legriel³  Jean-Pierre Quenot⁴  Gregoire Muller⁵  Jean Reignier⁶  J. B. Lascarrou⁷  Jean-Pierre Frat⁸  Michel Sirodot⁹  Mickael Landais^1,10  Didier Thevenin^1,11  Guillaume Grillet^1,12  Sylvie Vimeux^1,13  Jean-Charles Chakarian^1,14  Arnaud Delahaye^1,15  Nicolas Massart^1,16  Bruno Francois^1,17 

[1] AfterROSC Network, Paris, France;Medical Intensive Care Unit, University Hospital Center, Angers, France;AfterROSC Network, Paris, France;Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France;AfterROSC Network, Paris, France;Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles, France;Department of Intensive Care, Burgundy University Hospital, Dijon, France;Lipness Team, INSERM Research Center LNC-UMR1231, Dijon, France;LabEx LipSTIC, University of Burgundy, Dijon, France;INSERM CIC 1432, Clinical Epidemiology, University of Burgundy, Dijon, France;Medical Intensive Care Unit, Regional Hospital Center, Orleans, France;Medical Intensive Care Unit, Service de Médecine Intensive Réanimation, University Hospital Center, 30 Boulevard Jean Monnet, 44093, Paris, France;Medical Intensive Care Unit, Service de Médecine Intensive Réanimation, University Hospital Center, 30 Boulevard Jean Monnet, 44093, Paris, France;Paris Cardiovascular Research Center, INSERM U970, Paris, France;AfterROSC Network, Paris, France;Medical Intensive Care Unit, University Hospital Center, Poitiers, France;INSERM, CIC-1402, équipe ALIVE, Poitiers, France;Poitiers School of Medicine and Pharmacy, Poitiers University, Poitiers, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Lens, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Lorient, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez, France;Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc, France;Medical-Surgical Intensive Care Unit, University Hospital Center, Limoges, France;INSERM CIC 1435 & UMR 1092, University Hospital Center, Limoges, France;

关键词: Cardiac arrest;    Targeted temperature management;    Therapeutic hypothermia;   

DOI  :  10.1186/s13613-021-00947-w

来源: Springer

【 摘 要 】

BackgroundFew data are available about outcomes of patients screened for, but not enrolled in, randomised clinical trials.MethodsWe retrospectively reviewed patients who had non-inclusion criteria for the HYPERION trial comparing 33 °C to 37 °C in patients comatose after cardiac arrest in non-shockable rhythm, due to any cause. A good neurological outcome was defined as a day-90 Cerebral Performance Category score of 1 or 2.ResultsOf the 1144 patients with non-inclusion criteria, 1130 had day-90 information and, among these, 158 (14%) had good functional outcomes, compared to 7.9% overall in the HYPERION trial (10.2% with and 5.7% without hypothermia). Considerable centre-to-centre variability was found in the proportion of non-included patients who received hypothermia (0% to 83.8%) and who had good day-90 functional outcomes (0% to 31.3%). The proportion of patients with a good day-90 functional outcome was significantly higher with than without hypothermia (18.5% vs. 11.9%, P = 0.003).ConclusionOur finding of better functional outcomes without than with inclusion in the HYPERION trial, despite most non-inclusion criteria being of adverse prognostic significance (e.g., long no-flow and low-flow times and haemodynamic instability), raises important questions about the choice of patient selection criteria and the applicability of trial results to everyday practice. At present, reserving hypothermia for patients without predictors of poor prognosis seems open to criticism.

【 授权许可】

CC BY