Insights from patients screened but not randomised in the HYPERION trial

Autor: J. B. Lascarrou, Gregoire Muller, Jean-Pierre Quenot, Nicolas Massart, Mickael Landais, Pierre Asfar, Jean-Pierre Frat, Jean-Charles Chakarian, Michel Sirodot, Bruno Francois, Guillaume Grillet, Sylvie Vimeux, Arnaud Delahaye, Stéphane Legriel, Didier Thevenin, Jean Reignier, Gwenhael Colin, for the AfterROSC Network
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Annals of Intensive Care, Vol 11, Iss 1, Pp 1-5 (2021)
Druh dokumentu: article
ISSN: 2110-5820
DOI: 10.1186/s13613-021-00947-w
Popis: Abstract 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.
Databáze: Directory of Open Access Journals