Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
- Conditions
- Cardiogenic Shock
- Interventions
- Other: moderate hypothermia
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
- Age ≥ 18 years
- Intubated patients with cardiogenic shock treated with VA-ECMO
- Patient affiliated to social security plan
- 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
- Arm && Interventions
Group Intervention Description Moderate hypothermia moderate hypothermia 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
- 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)
APHP- Hôpital Bichat
🇫🇷Paris, France
CHU Besançon Hôpital Jean Minjoz
🇫🇷Besancon, France
CHU Bordeaux - Groupe Hospitalier SaintAndré
🇫🇷Bordeaux, France
CHRU Strasbourg
🇫🇷Strasbourg, France
CHU Strasbourg/ NHC
🇫🇷Strasbourg, France
CHU Toulouse Hôpital - Pierre Paul Riquet
🇫🇷Toulouse, France
CHRU Nancy
🇫🇷Vandoeuvre les Nancy, France
CHU Amiens - Picardie -Site sud
🇫🇷Amiens, France
CH Annecy Centre Hospitalier
🇫🇷Annecy, France
CHU Montpellier
🇫🇷Montpellier, France
CHU Clermont-Ferrand -Hopital G. Montpied
🇫🇷Clermont-Ferrand, France
APHM-Hôpital, de la Timone
🇫🇷Marseille, France
CHU Lyon - Hôpital Louis Pradel
🇫🇷Lyon, France
CHU Grenoble
🇫🇷Grenoble, France
APHP-Pitié
🇫🇷Paris, France
Chu Rouen
🇫🇷Rouen, France
APHP- la Pitié Sapêtrière
🇫🇷Paris, France
CHU Nantes/ Hôpital Nord Laennec
🇫🇷Nantes, France
Aphp-Hegp
🇫🇷Paris, France
CHU Rennes Hôpital Pontchaillou
🇫🇷Rennes, France