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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
moderate hypothermia will be induced using the heat controller of the VA-ECMO circuit. Temperature will be maintained between 33°C≤ T°C ≤34°C during 24 hours ± 1h followed by a progressive reheating (0.2±0.1°C/h) to reach 37 °C. Temperature at 37°C ± 0.3°C will be maintained during 48 hours ± 4h after having reached 37 °C.
CHU Amiens - Picardie -Site sud
Amiens, France
CH Annecy Centre Hospitalier
Annecy, France
CHU Besançon Hôpital Jean Minjoz
Besançon, 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
...and 10 more locations
All-cause Mortality
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
Time frame: Day 30
All-cause mortality
Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days
Time frame: Hour 48, Day 7, Day 60, day 180
Venous Arterial ECMO duration
Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time
Time frame: up to 180 days (from date of randomization until ECMO weaning)
Death
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)
Time frame: day 30, Day 60, Day 180
cardiac transplant
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)
Time frame: day 30, Day 60, Day 180
escalation to Left Ventricular Assist Device
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)
Time frame: day 30, Day 60, Day180
Stroke
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)
Time frame: Day 30, Day 60, Day 180
Cumulated amount of administered fluids
Evaluation of the impact of moderate hypothermia on necessity of fluid
Time frame: up to 180 days (from date of randomization until ECMO weaning)
Cumulated amount of vasopressors use
Evaluation of the impact of moderate hypothermia on necessity of vasopressor (norepinephrine, epinephrine)
Time frame: up to 180 days (from date of randomization until ECMO weaning)
Lactate
Evaluation of the impact of moderate hypothermia on lactate clearance
Time frame: up to 180 days (from date of randomization until ECMO weaning)
SOFA score
Evaluation of the impact of moderate hypothermia on duration of organ failure
Time frame: from baseline until Day 30
Mechanical ventilation
Evaluation of the impact of moderate hypothermia on mechanical ventilation support use
Time frame: baseline, day 30, day 60 and day 180
Renal replacement therapy
Evaluation of the impact of moderate hypothermia on renal replacement therapy use
Time frame: from baseline until day 30, day 60, day 180
Intensive care unit stay
Evaluation of the impact of moderate hypothermia on duration of ICU stay
Time frame: Day 30; Day 60; Day 180
hospitalization stay
Evaluation of the impact of moderate hypothermia on duration of total hospitalization
Time frame: Day 30; Day 60; Day 180
bleeding complications
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
Time frame: Hour 48, Day 7
packed red blood cells transfused
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
Time frame: Hour 48, Day 7
Infection
Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes)
Time frame: Hour 48, Day 7, Day 30, Day 60, day 180
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.