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

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      , , , , , , , , , , , , , , , , , , , , , , , , , for the Clinical Research in Intensive Care and Sepsis (CRICS) Group and the HYPERION Study Group
      Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
      BioMed Central
      Cardiac arrest, Therapeutic hypothermia, Nonshockable rhythm

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          Abstract

          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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          Most cited references55

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          Progress in development of the index of ADL.

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            Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. A statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council.

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              Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest.

              Epinephrine is widely used in cardiopulmonary resuscitation for out-of-hospital cardiac arrest (OHCA). However, the effectiveness of epinephrine use before hospital arrival has not been established. To evaluate the association between epinephrine use before hospital arrival and short- and long-term mortality in patients with cardiac arrest. Prospective, nonrandomized, observational propensity analysis of data from 417 188 OHCAs occurring in 2005-2008 in Japan in which patients aged 18 years or older had an OHCA before arrival of emergency medical service (EMS) personnel, were treated by EMS personnel, and were transported to the hospital. Return of spontaneous circulation before hospital arrival, survival at 1 month after cardiac arrest, survival with good or moderate cerebral performance (Cerebral Performance Category [CPC] 1 or 2), and survival with no, mild, or moderate neurological disability (Overall Performance Category [OPC] 1 or 2). Return of spontaneous circulation before hospital arrival was observed in 2786 of 15,030 patients (18.5%) in the epinephrine group and 23,042 of 402,158 patients (5.7%) in the no-epinephrine group (P < .001); it was observed in 2446 (18.3%) and 1400 (10.5%) of 13,401 propensity-matched patients, respectively (P < .001). In the total sample, the numbers of patients with 1-month survival and survival with CPC 1 or 2 and OPC 1 or 2, respectively, were 805 (5.4%), 205 (1.4%), and 211 (1.4%) with epinephrine and 18,906 (4.7%), 8903 (2.2%), and 8831 (2.2%) without epinephrine (all P <.001). Corresponding numbers in propensity-matched patients were 687 (5.1%), 173 (1.3%), and 178 (1.3%) with epinephrine and 944 (7.0%), 413 (3.1%), and 410 (3.1%) without epinephrine (all P <.001). In all patients, a positive association was observed between prehospital epinephrine and return of spontaneous circulation before hospital arrival (adjusted odds ratio [OR], 2.36; 95% CI, 2.22-2.50; P < .001). In propensity-matched patients, a positive association was also observed (adjusted OR, 2.51; 95% CI, 2.24-2.80; P < .001). In contrast, among all patients, negative associations were observed between prehospital epinephrine and long-term outcome measures (adjusted ORs: 1-month survival, 0.46 [95% CI, 0.42-0.51]; CPC 1-2, 0.31 [95% CI, 0.26-0.36]; and OPC 1-2, 0.32 [95% CI, 0.27-0.38]; all P < .001). Similar negative associations were observed among propensity-matched patients (adjusted ORs: 1-month survival, 0.54 [95% CI, 0.43-0.68]; CPC 1-2, 0.21 [95% CI, 0.10-0.44]; and OPC 1-2, 0.23 [95% CI, 0.11-0.45]; all P < .001). Among patients with OHCA in Japan, use of prehospital epinephrine was significantly associated with increased chance of return of spontaneous circulation before hospital arrival but decreased chance of survival and good functional outcomes 1 month after the event.
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                Author and article information

                Contributors
                jean-baptiste.lascarrou@chd-vendee.fr
                ferhat.meziani@chru-strasbourg.fr
                amelie.legouge@univ-tours.fr
                thierry.boulain@chr-orleans.fr
                jerome.bousser@ch-stbrieuc.fr
                belliardguillaume@orange.fr
                PiAsfar@chu-angers.fr
                Jean-Pierre.FRAT@chu-poitiers.fr
                pierre-francois.dequin@univ-tours.fr
                jp.gouello@ch-stmalo.fr
                a.delahaye@ch-rodez.fr
                aait_hssain@chu-clermontferrand.fr
                jean-charles.chakarian@ch-roanne.fr
                nicolas.pichon@chu-limoges.fr
                arnaud.desachy@ch-angouleme.fr
                f.bellec@ch-montauban.fr
                dthevenin@ch-lens.fr
                jean-pierre.quenot@chu-dijon.fr
                msirodot@ch-annecygenevois.fr
                f.labadie@ch-saintnazaire.fr
                gaetan.plantefeve@ch-argenteuil.fr
                dvivier@ch-lemans.fr
                patrick.girardie@chru-lille.fr
                bruno.giraudeau@univ-tours.fr
                jean.reignier@chd-vendee.fr
                Journal
                Scand J Trauma Resusc Emerg Med
                Scand J Trauma Resusc Emerg Med
                Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
                BioMed Central (London )
                1757-7241
                7 March 2015
                7 March 2015
                2015
                : 23
                : 26
                Affiliations
                [ ]Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France
                [ ]Medical Intensive Care Unit, University Hospital Center, University of Strasbourg, Strasbourg, France
                [ ]INSERM CIC1415, CHRU de Tours, Tours, France
                [ ]Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France
                [ ]Medical Intensive Care Unit, Regional Hospital Center, Orleans, France
                [ ]Medical-Surgical intensive Care Unit, General Hospital Center, Saint Brieuc, France
                [ ]Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient, France
                [ ]Medical Intensive Care Unit, University Hospital Center, Angers, France
                [ ]Medical Intensive Care Unit, University Hospital Center, Poitiers, France
                [ ]Medical Intensive Care Unit, University Hospital Center, Tours, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez, France
                [ ]Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne, France
                [ ]Medical-Surgical Intensive Care Unit, University Hospital Center, Limoges, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Lens, France
                [ ]Medical Intensive Care Unit, University Hospital Center, Dijon, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Nazaire, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil, France
                [ ]Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans, France
                [ ]Medical Intensive Care Unit, University Hospital Center, Lille, France
                Article
                103
                10.1186/s13049-015-0103-5
                4353458
                25882712
                751513f8-9b95-44bf-bce3-04f7859c30c5
                © 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.

                History
                : 6 November 2014
                : 11 February 2015
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                Emergency medicine & Trauma
                cardiac arrest,therapeutic hypothermia,nonshockable rhythm
                Emergency medicine & Trauma
                cardiac arrest, therapeutic hypothermia, nonshockable rhythm

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