Insights from patients screened but not randomised in the HYPERION trial

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 i...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	SpringerOpen 2021
Materias:	Cardiac arrest Targeted temperature management Therapeutic hypothermia Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
Acceso en línea:	https://doaj.org/article/95ba8b023892423786ace10041f2a030
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spelling	oai:doaj.org-article:95ba8b023892423786ace10041f2a0302021-11-21T12:02:39ZInsights from patients screened but not randomised in the HYPERION trial10.1186/s13613-021-00947-w2110-5820https://doaj.org/article/95ba8b023892423786ace10041f2a0302021-11-01T00:00:00Zhttps://doi.org/10.1186/s13613-021-00947-whttps://doaj.org/toc/2110-5820Abstract 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.J. B. LascarrouGregoire MullerJean-Pierre QuenotNicolas MassartMickael LandaisPierre AsfarJean-Pierre FratJean-Charles ChakarianMichel SirodotBruno FrancoisGuillaume GrilletSylvie VimeuxArnaud DelahayeStéphane LegrielDidier TheveninJean ReignierGwenhael Colinfor the AfterROSC NetworkSpringerOpenarticleCardiac arrestTargeted temperature managementTherapeutic hypothermiaMedical emergencies. Critical care. Intensive care. First aidRC86-88.9ENAnnals of Intensive Care, Vol 11, Iss 1, Pp 1-5 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Cardiac arrest Targeted temperature management Therapeutic hypothermia Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
spellingShingle	Cardiac arrest Targeted temperature management Therapeutic hypothermia Medical emergencies. Critical care. Intensive care. First aid RC86-88.9 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 Insights from patients screened but not randomised in the HYPERION trial
description	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.
format	article
author	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
author_facet	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
author_sort	J. B. Lascarrou
title	Insights from patients screened but not randomised in the HYPERION trial
title_short	Insights from patients screened but not randomised in the HYPERION trial
title_full	Insights from patients screened but not randomised in the HYPERION trial
title_fullStr	Insights from patients screened but not randomised in the HYPERION trial
title_full_unstemmed	Insights from patients screened but not randomised in the HYPERION trial
title_sort	insights from patients screened but not randomised in the hyperion trial
publisher	SpringerOpen
publishDate	2021
url	https://doaj.org/article/95ba8b023892423786ace10041f2a030
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Insights from patients screened but not randomised in the HYPERION trial

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