CompletedNot Applicable

Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)

France334 participantsStarted 2016-10-10

Plain-language summary

A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C) during 24 hours ± 1h versus normothermia (36°C≤ T°C ≤37°C), comparative open trial will be conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO. The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between 33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality in comparison with the normothermia group (36°C≤ T°C ≤37°C).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Intubated patients with cardiogenic shock treated with VA-ECMO * Patient affiliated to social security plan Exclusion Criteria: * VA-ECMO after cardiac surgery for heart transplantation or lung transplantation or left or biventricular assist device implantation * VA-ECMO for acute poisoning with cardio-toxic drugs * Pregnancy * Uncontrolled bleeding (bleeding despite medical intervention (surgery or drugs)) * Implantation of VA ECMO under cardiac massage with a duration of cardiac massage \>45minutes * Out of hospital refractory cardiac arrest * Cerebral deficit with fixed dilated pupils * Participation in another interventional research involving therapeutic modifications * Patient moribund on the day of randomization * Irreversible neurological pathology * Minor patients * Patients under tutelage

What they're measuring

All-cause Mortality

Timeframe: Day 30

Trial details

NCT IDNCT02754193

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-28