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

Central Hospital, Nancy, France

Status: Completed

Conditions: Cardiogenic Shock

Treatments: Other: moderate hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT02754193

2016-A00377-44

Details and patient eligibility

About

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).

Enrollment: 334 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

Moderate hypothermia

Experimental group

Description:

Moderate hypothermia :Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of moderate hypothermia during 24 hours (Temperature at 33°C≤ T°C ≤34°C) associated with usual care

Treatment:

Other: moderate hypothermia

Normothermia

No Intervention group

Description:

Normothermia: Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of normothermia (36°C≤ T°C ≤37°C) associated with usual care