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

C

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)

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

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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