{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T16:25:40Z","timestamp":1791390340655,"version":"4.3.3"},"reference-count":15,"publisher":"BMJ","issue":"10","funder":[{"name":"Programme Hospitalier de Recherche Clinique","award":["PHRC-15-445"],"award-info":[{"award-number":["PHRC-15-445"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,8,16]]},"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is widely used to support the most severe forms of cardiogenic shock (CS). Nevertheless, despite extracorporeal membrane oxygenation (ECMO) use, mortality still remains high (50%). Moderate hypothermia (MH) (33\u00b0C\u201334\u00b0C) may improve cardiac performance and decrease ischaemia\u2013reperfusion injuries. The use of MH during VA-ECMO is strongly supported by experimental and preliminary clinical data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The Hypothermia-Extracorporeal Membrane Oxygenation (HYPO-ECMO) study is a multicentre, prospective, controlled randomised trial between an MH group (33\u00b0C\u2264T\u00b0C\u226434\u00b0C) and normothermia group (36\u00b0C\u2264T\u00b0C\u226437\u00b0C). The primary endpoint is all-cause mortality at day 30 following randomisation. The study will also assess as secondary endpoints the effects of targeted temperature management strategies on (1) mortality rate at different time points, (2) organ failure and supportive treatment use and (3) safety. All intubated adults with refractory CS supported with VA-ECMO will be screened. Exclusion criteria are patients having undergone cardiac surgery for heart transplantation or left or biventricular assist device implantation, acute poisoning with cardiotoxic drugs, pregnancy, uncontrolled bleeding and refractory cardiac arrest.<\/jats:p>\n                    <jats:p>Three-hundred and thirty-four patients will be randomised and followed up to 6 months to detect a 15% difference in mortality. Data analysis will be intention to treat. The differences between the two study groups in the risk of all-cause mortality at day 30 following randomisation will be studied using logistic regression analysis adjusted for postcardiotomy setting, prior cardiac arrest, prior myocardial infarction, age, vasopressor dose, Sepsis-related Organ Failure Assessment (SOFA) score and lactate at randomisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics approval has been granted by the Comit\u00e9 de Protection des Personnes Est III Ethics Committee. The trial has been approved by the French Health Authorities (Agence Nationale de la S\u00e9curit\u00e9 du M\u00e9dicament et des Produits de Sant\u00e9). Dissemination of results will be performed via journal articles and presentations at national and international conferences. Since this study is also the first step in the constitution of an \u2018ECMO Trials Group\u2019, its results will also be disseminated by the aforementioned group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NCT 02754193.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-031697","type":"journal-article","created":{"date-parts":[[2019,10,15]],"date-time":"2019-10-15T06:15:36Z","timestamp":1571120136000},"page":"e031697","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study)"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03813134","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03637205","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Audrey","family":"Jacquot","sequence":"first","affiliation":[{"name":"Medical Intensive Care Unit, Institut Lorrain du Coeur et des Vaisseaux, CHRU Nancy-H\u00f4pitaux de Brabois, Vandoeuvre-l\u00e8s-Nancy, Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Lepage","sequence":"additional","affiliation":[{"name":"Centre d'Investigation Clinique 1433, module Plurith\u00e9matique, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, CHRU Nancy - Hopitaux de Brabois, Vandoeuvre-l\u00e8s-Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludovic","family":"Merckle","sequence":"additional","affiliation":[{"name":"Centre d'Investigation Clinique 1433, module Plurith\u00e9matique, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, CHRU Nancy - Hopitaux de Brabois, Vandoeuvre-l\u00e8s-Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Girerd","sequence":"additional","affiliation":[{"name":"INSERM, Centre d\u2019Investigation Clinique 1433, Universit\u00e9 de Lorraine, CHRU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, H\u00f4pitaux de Brabois, Vandoeuvre-l\u00e8s-Nancy, France, Inserm 1116 and INI-CRCT (Cardiovascular and Renal Clinical Trialists) F-CRIN Network, Vandoeuvre les Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Levy","sequence":"additional","affiliation":[{"name":"Groupe Choc, \u00e9quipe 2, Inserm U1116, Vandoeuvre les Nancy, France"},{"name":"University de Lorraine, 54000, Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,10,14]]},"reference":[{"key":"2025121509294824000_9.10.e031697.1","article-title":"Experts' recommendations for the management of adult patients with cardiogenic shock","volume":"5","author":"Levy","year":"2015","journal-title":"Ann Intensive Care"},{"key":"2025121509294824000_9.10.e031697.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1208410"},{"key":"2025121509294824000_9.10.e031697.3","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv051"},{"key":"2025121509294824000_9.10.e031697.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.11.010"},{"key":"2025121509294824000_9.10.e031697.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1310519"},{"key":"2025121509294824000_9.10.e031697.6","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e3181aa5241"},{"key":"2025121509294824000_9.10.e031697.7","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1016\/S0022-5223(19)41389-5","article-title":"Induced hypothermia in dogs with acute myocardial infarction and shock","volume":"74","author":"Boyer","year":"1977","journal-title":"J Thorac Cardiovasc Surg"},{"key":"2025121509294824000_9.10.e031697.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.resuscitation.2010.04.033"},{"key":"2025121509294824000_9.10.e031697.9","doi-asserted-by":"publisher","DOI":"10.1152\/ajpcell.00287.2008"},{"key":"2025121509294824000_9.10.e031697.10","doi-asserted-by":"publisher","DOI":"10.1152\/ajpheart.00805.2009"},{"key":"2025121509294824000_9.10.e031697.11","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e318246b820"},{"key":"2025121509294824000_9.10.e031697.12","doi-asserted-by":"crossref","first-page":"448","DOI":"10.1161\/CIRCULATIONAHA.117.032722","article-title":"Mild hypothermia in cardiogenic shock complicating myocardial infarction","volume":"139","author":"Fuernau","year":"2019","journal-title":"Circulation"},{"key":"2025121509294824000_9.10.e031697.13","doi-asserted-by":"crossref","first-page":"1733","DOI":"10.1007\/s12013-014-0121-3","article-title":"Utilization of extracorporeal membrane oxygenation alleviates intestinal ischemia-reperfusion injury in prolonged hemorrhagic shock animal model","volume":"70","author":"Zhao","year":"2014","journal-title":"Cell Biochem Biophys"},{"key":"2025121509294824000_9.10.e031697.14","doi-asserted-by":"crossref","first-page":"236","DOI":"10.1097\/SHK.0000000000000712","article-title":"Moderate hypothermia improves cardiac and vascular function in a pig model of ischemic cardiogenic shock treated with veno-arterial ECMO","volume":"47","author":"Vanhuyse","year":"2017","journal-title":"Shock"},{"key":"2025121509294824000_9.10.e031697.15","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.01.069"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-031697","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T17:29:53Z","timestamp":1765819793000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-031697"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10]]},"references-count":15,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2019,10,14]]},"published-print":{"date-parts":[[2019,10]]}},"alternative-id":["10.1136\/bmjopen-2019-031697"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-031697","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10]]}}}