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Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial

BACKGROUND: Meta-analyses of nonrandomized studies have provided conflicting data on therapeutic hypothermia, or targeted temperature management (TTM), at 33°C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the Internationa...

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Autores principales: Lascarrou, Jean Baptiste, Meziani, Ferhat, Le Gouge, Amélie, Boulain, Thierry, Bousser, Jérôme, Belliard, Guillaume, Asfar, Pierre, Frat, Jean Pierre, Dequin, Pierre François, Gouello, Jean Paul, Delahaye, Arnaud, Hssain, Ali Ait, Chakarian, Jean Charles, Pichon, Nicolas, Desachy, Arnaud, Bellec, Fréderic, Thevenin, Didier, Quenot, Jean Pierre, Sirodot, Michel, Labadie, François, Plantefeve, Gaétan, Vivier, Dominique, Girardie, Patrick, Giraudeau, Bruno, Reignier, Jean
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4353458/
https://www.ncbi.nlm.nih.gov/pubmed/25882712
http://dx.doi.org/10.1186/s13049-015-0103-5
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author Lascarrou, Jean Baptiste
Meziani, Ferhat
Le Gouge, Amélie
Boulain, Thierry
Bousser, Jérôme
Belliard, Guillaume
Asfar, Pierre
Frat, Jean Pierre
Dequin, Pierre François
Gouello, Jean Paul
Delahaye, Arnaud
Hssain, Ali Ait
Chakarian, Jean Charles
Pichon, Nicolas
Desachy, Arnaud
Bellec, Fréderic
Thevenin, Didier
Quenot, Jean Pierre
Sirodot, Michel
Labadie, François
Plantefeve, Gaétan
Vivier, Dominique
Girardie, Patrick
Giraudeau, Bruno
Reignier, Jean
author_facet Lascarrou, Jean Baptiste
Meziani, Ferhat
Le Gouge, Amélie
Boulain, Thierry
Bousser, Jérôme
Belliard, Guillaume
Asfar, Pierre
Frat, Jean Pierre
Dequin, Pierre François
Gouello, Jean Paul
Delahaye, Arnaud
Hssain, Ali Ait
Chakarian, Jean Charles
Pichon, Nicolas
Desachy, Arnaud
Bellec, Fréderic
Thevenin, Didier
Quenot, Jean Pierre
Sirodot, Michel
Labadie, François
Plantefeve, Gaétan
Vivier, Dominique
Girardie, Patrick
Giraudeau, Bruno
Reignier, Jean
author_sort Lascarrou, Jean Baptiste
collection PubMed
description BACKGROUND: Meta-analyses of nonrandomized studies have provided conflicting data on therapeutic hypothermia, or targeted temperature management (TTM), at 33°C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the International Liaison Committee on Resuscitation and by the European Resuscitation Council recommend therapeutic hypothermia. New data are available on the adverse effects of therapeutic hypothermia, notably infectious complications. The risk/benefit ratio of therapeutic hypothermia after nonshockable cardiac arrest is unclear. METHODS: HYPERION is a multicenter (22 French ICUs) trial with blinded outcome assessment in which 584 patients with successfully resuscitated nonshockable cardiac arrest are allocated at random to either TTM between 32.5 and 33.5°C (therapeutic hypothermia) or TTM between 36.5 and 37.5°C (therapeutic normothermia) for 24 hours. Both groups are managed with therapeutic normothermia for the next 24 hours. TTM is achieved using locally available equipment. The primary outcome is day-90 neurological status assessed by the Cerebral Performance Categories (CPC) Scale with dichotomization of the results (1 + 2 versus 3 + 4 + 5). The primary outcome is assessed by a blinded psychologist during a semi-structured telephone interview of the patient or next of kin. Secondary outcomes are day-90 mortality, hospital mortality, severe adverse events, infections, and neurocognitive performance. The planned sample size of 584 patients will enable us to detect a 9% absolute difference in day-90 neurological status with 80% power, assuming a 14% event rate in the control group and a two-sided Type 1 error rate of 4.9%. Two interim analyses will be performed, after inclusion of 200 and 400 patients, respectively. DISCUSSION: The HYPERION trial is a multicenter, randomized, controlled, assessor-blinded, superiority trial that may provide an answer to an issue of everyday relevance, namely, whether TTM is beneficial in comatose patients resuscitated after nonshockable cardiac arrest. Furthermore, it will provide new data on the tolerance and adverse events (especially infectious complications) of TTM at 32.5-33.5°C. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01994772.
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spelling pubmed-43534582015-03-10 Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial Lascarrou, Jean Baptiste Meziani, Ferhat Le Gouge, Amélie Boulain, Thierry Bousser, Jérôme Belliard, Guillaume Asfar, Pierre Frat, Jean Pierre Dequin, Pierre François Gouello, Jean Paul Delahaye, Arnaud Hssain, Ali Ait Chakarian, Jean Charles Pichon, Nicolas Desachy, Arnaud Bellec, Fréderic Thevenin, Didier Quenot, Jean Pierre Sirodot, Michel Labadie, François Plantefeve, Gaétan Vivier, Dominique Girardie, Patrick Giraudeau, Bruno Reignier, Jean Scand J Trauma Resusc Emerg Med Study Protocol BACKGROUND: Meta-analyses of nonrandomized studies have provided conflicting data on therapeutic hypothermia, or targeted temperature management (TTM), at 33°C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the International Liaison Committee on Resuscitation and by the European Resuscitation Council recommend therapeutic hypothermia. New data are available on the adverse effects of therapeutic hypothermia, notably infectious complications. The risk/benefit ratio of therapeutic hypothermia after nonshockable cardiac arrest is unclear. METHODS: HYPERION is a multicenter (22 French ICUs) trial with blinded outcome assessment in which 584 patients with successfully resuscitated nonshockable cardiac arrest are allocated at random to either TTM between 32.5 and 33.5°C (therapeutic hypothermia) or TTM between 36.5 and 37.5°C (therapeutic normothermia) for 24 hours. Both groups are managed with therapeutic normothermia for the next 24 hours. TTM is achieved using locally available equipment. The primary outcome is day-90 neurological status assessed by the Cerebral Performance Categories (CPC) Scale with dichotomization of the results (1 + 2 versus 3 + 4 + 5). The primary outcome is assessed by a blinded psychologist during a semi-structured telephone interview of the patient or next of kin. Secondary outcomes are day-90 mortality, hospital mortality, severe adverse events, infections, and neurocognitive performance. The planned sample size of 584 patients will enable us to detect a 9% absolute difference in day-90 neurological status with 80% power, assuming a 14% event rate in the control group and a two-sided Type 1 error rate of 4.9%. Two interim analyses will be performed, after inclusion of 200 and 400 patients, respectively. DISCUSSION: The HYPERION trial is a multicenter, randomized, controlled, assessor-blinded, superiority trial that may provide an answer to an issue of everyday relevance, namely, whether TTM is beneficial in comatose patients resuscitated after nonshockable cardiac arrest. Furthermore, it will provide new data on the tolerance and adverse events (especially infectious complications) of TTM at 32.5-33.5°C. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01994772. BioMed Central 2015-03-07 /pmc/articles/PMC4353458/ /pubmed/25882712 http://dx.doi.org/10.1186/s13049-015-0103-5 Text en © Lascarrou et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Lascarrou, Jean Baptiste
Meziani, Ferhat
Le Gouge, Amélie
Boulain, Thierry
Bousser, Jérôme
Belliard, Guillaume
Asfar, Pierre
Frat, Jean Pierre
Dequin, Pierre François
Gouello, Jean Paul
Delahaye, Arnaud
Hssain, Ali Ait
Chakarian, Jean Charles
Pichon, Nicolas
Desachy, Arnaud
Bellec, Fréderic
Thevenin, Didier
Quenot, Jean Pierre
Sirodot, Michel
Labadie, François
Plantefeve, Gaétan
Vivier, Dominique
Girardie, Patrick
Giraudeau, Bruno
Reignier, Jean
Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial
title Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial
title_full Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial
title_fullStr Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial
title_full_unstemmed Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial
title_short Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial
title_sort therapeutic hypothermia after nonshockable cardiac arrest: the hyperion multicenter, randomized, controlled, assessor-blinded, superiority trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4353458/
https://www.ncbi.nlm.nih.gov/pubmed/25882712
http://dx.doi.org/10.1186/s13049-015-0103-5
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