Insights from patients screened but not randomised in the HYPERION trial.

Autor:	Lascarrou JB; Medical Intensive Care Unit, Service de Médecine Intensive Réanimation, University Hospital Center, 30 Boulevard Jean Monnet, 44093, Paris, France. Jeanbaptiste.lascarrou@chu-nantes.fr.; Paris Cardiovascular Research Center, INSERM U970, Paris, France. Jeanbaptiste.lascarrou@chu-nantes.fr.; AfterROSC Network, Paris, France. Jeanbaptiste.lascarrou@chu-nantes.fr., Muller G; Medical Intensive Care Unit, Regional Hospital Center, Orleans, France., Quenot JP; 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., Massart N; Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc, France., Landais M; Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans, France., Asfar P; AfterROSC Network, Paris, France.; Medical Intensive Care Unit, University Hospital Center, Angers, France., Frat JP; 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., Chakarian JC; Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne, France., Sirodot M; Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy, France., Francois B; Medical-Surgical Intensive Care Unit, University Hospital Center, Limoges, France.; INSERM CIC 1435 & UMR 1092, University Hospital Center, Limoges, France., Grillet G; Medical-Surgical Intensive Care Unit, General Hospital Center, Lorient, France., Vimeux S; Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban, France., Delahaye A; Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez, France., Legriel S; AfterROSC Network, Paris, France.; Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles, France., Thevenin D; Medical-Surgical Intensive Care Unit, General Hospital Center, Lens, France., Reignier J; Medical Intensive Care Unit, Service de Médecine Intensive Réanimation, University Hospital Center, 30 Boulevard Jean Monnet, 44093, Paris, France., Colin G; AfterROSC Network, Paris, France.; Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France.
Jazyk:	angličtina
Zdroj:	Annals of intensive care [Ann Intensive Care] 2021 Nov 14; Vol. 11 (1), pp. 156. Date of Electronic Publication: 2021 Nov 14.
DOI:	10.1186/s13613-021-00947-w
Abstrakt:	Background: Few data are available about outcomes of patients screened for, but not enrolled in, randomised clinical trials. Methods: We 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. Results: Of 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). Conclusion: Our 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. (© 2021. The Author(s).)
Databáze:	MEDLINE
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