Cardiogenic Shock
Conditions
Keywords
Venous-Arterial ExtraCorporeal Membrane Oxygenation
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).
Interventions
OTHERmoderate hypothermia
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.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Lactate | up to 180 days (from date of randomization until ECMO weaning) | Evaluation of the impact of moderate hypothermia on lactate clearance |
| SOFA score | from baseline until Day 30 | Evaluation of the impact of moderate hypothermia on duration of organ failure |
| 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 |
| Intensive care unit stay | Day 30; Day 60; Day 180 | Evaluation of the impact of moderate hypothermia on duration of ICU stay |
| 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 |
| packed red blood cells transfused | Hour 48, Day 7 | Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO |
| 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) |
Countries
France
Outcome results
None listed