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

Not Applicable

Completed

• Conditions: Cardiogenic Shock

• Registration Number: NCT02754193
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Study Start: 2016-10-10
• Primary Completion: 2019-07-28
• Study Completion: 2019-11-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	Day 30	The study objective is to determine whether early moderate hypothermia (33°C≤ T°C ≤34°C) is superior to normothermia (37°C ± 0.3°C) in patients with cardiogenic shock treated with VA-ECMO with respect to 30-day mortality

Secondary Outcome Measures

Name	Time	Method
Death	day 30, Day 60, Day 180	Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7)
Lactate	up to 180 days (from date of randomization until ECMO weaning)	Evaluation of the impact of moderate hypothermia on lactate clearance
Mechanical ventilation	baseline, day 30, day 60 and day 180	Evaluation of the impact of moderate hypothermia on mechanical ventilation support use
Renal replacement therapy	from baseline until day 30, day 60, day 180	Evaluation of the impact of moderate hypothermia on renal replacement therapy use
packed red blood cells transfused	Hour 48, Day 7	Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
All-cause mortality	Hour 48, Day 7, Day 60, day 180	Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days
Stroke	Day 30, Day 60, Day 180	Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7)
Venous Arterial ECMO duration	up to 180 days (from date of randomization until ECMO weaning)	Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time
cardiac transplant	day 30, Day 60, Day 180	Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7)
SOFA score	from baseline until Day 30	Evaluation of the impact of moderate hypothermia on duration of organ failure
Intensive care unit stay	Day 30; Day 60; Day 180	Evaluation of the impact of moderate hypothermia on duration of ICU stay
escalation to Left Ventricular Assist Device	day 30, Day 60, Day180	Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7)
Cumulated amount of administered fluids	up to 180 days (from date of randomization until ECMO weaning)	Evaluation of the impact of moderate hypothermia on necessity of fluid
Cumulated amount of vasopressors use	up to 180 days (from date of randomization until ECMO weaning)	Evaluation of the impact of moderate hypothermia on necessity of vasopressor (norepinephrine, epinephrine)
Infection	Hour 48, Day 7, Day 30, Day 60, day 180	Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes)
hospitalization stay	Day 30; Day 60; Day 180	Evaluation of the impact of moderate hypothermia on duration of total hospitalization
bleeding complications	Hour 48, Day 7	Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO

Trial Locations

Locations (20)

CHU Amiens - Picardie -Site sud; 🇫🇷 Amiens, France

CH Annecy Centre Hospitalier; 🇫🇷 Annecy, France

CHU Besançon Hôpital Jean Minjoz; 🇫🇷 Besancon, France

CHU Bordeaux - Groupe Hospitalier SaintAndré; 🇫🇷 Bordeaux, France

CHU Clermont-Ferrand -Hopital G. Montpied; 🇫🇷 Clermont-Ferrand, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Lyon - Hôpital Louis Pradel; 🇫🇷 Lyon, France

APHM-Hôpital, de la Timone; 🇫🇷 Marseille, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nantes/ Hôpital Nord Laennec; 🇫🇷 Nantes, France

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