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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Other: moderate hypothermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate hypothermia<br>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 | Other: moderate hypothermia<br>* 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.<br>|
| No Intervention: Normothermia<br>Normothermia: Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of normothermia (36°C≤ T°C ≤37°C) associated with usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days | Hour 48, Day 7, Day 60, day 180 | 
| Venous Arterial ECMO duration | Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time | 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) | 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) | 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) | 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) | Day 30, Day 60, Day 180 | 
| Cumulated amount of administered fluids | Evaluation of the impact of moderate hypothermia on necessity of fluid | 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) | up to 180 days (from date of randomization until ECMO weaning) | 
| Lactate | Evaluation of the impact of moderate hypothermia on lactate clearance | 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 | from baseline until Day 30 | 
| Mechanical ventilation | Evaluation of the impact of moderate hypothermia on mechanical ventilation support use | baseline, day 30, day 60 and day 180 | 
| Renal replacement therapy | Evaluation of the impact of moderate hypothermia on renal replacement therapy use | 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 | Day 30; Day 60; Day 180 | 
| hospitalization stay | Evaluation of the impact of moderate hypothermia on duration of total hospitalization | Day 30; Day 60; Day 180 | 
| bleeding complications | Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO | Hour 48, Day 7 | 
| packed red blood cells transfused | Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO | Hour 48, Day 7 | 
| Infection | Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes) | Hour 48, Day 7, Day 30, Day 60, day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous-Arterial ExtraCorporeal Membrane Oxygenation