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

Cardiogenic Shock Clinical Trial

— HYPO-ECMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754193
• Other study ID #: 2016-A00377-44
• Status: Completed
• Phase: N/A
• Start date: October 10, 2016
• Est. completion date: November 13, 2019

Study information

• Verified date: March 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: November 13, 2019
• Est. primary completion date: July 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Hypothermia
• Shock
• Shock, Cardiogenic

Intervention

Other:
• moderate 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.

Locations

Country	Name	City	State
France	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	APHP- Hôpital Bichat	Paris
France	APHP- la Pitié Sapêtrière	Paris
France	Aphp-Hegp	Paris
France	APHP-Pitié	Paris
France	CHU Rennes Hôpital Pontchaillou	Rennes
France	Chu Rouen	Rouen
France	CHRU Strasbourg	Strasbourg
France	CHU Strasbourg/ NHC	Strasbourg
France	CHU Toulouse Hôpital - Pierre Paul Riquet	Toulouse
France	CHRU Nancy	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Lactate	Evaluation of the impact of moderate hypothermia on lactate clearance	up to 180 days (from date of randomization until ECMO weaning)
Secondary	SOFA score	Evaluation of the impact of moderate hypothermia on duration of organ failure	from baseline until Day 30
Secondary	Mechanical ventilation	Evaluation of the impact of moderate hypothermia on mechanical ventilation support use	baseline, day 30, day 60 and day 180
Secondary	Renal replacement therapy	Evaluation of the impact of moderate hypothermia on renal replacement therapy use	from baseline until day 30, day 60, day 180
Secondary	Intensive care unit stay	Evaluation of the impact of moderate hypothermia on duration of ICU stay	Day 30; Day 60; Day 180
Secondary	hospitalization stay	Evaluation of the impact of moderate hypothermia on duration of total hospitalization	Day 30; Day 60; Day 180
Secondary	bleeding complications	Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO	Hour 48, Day 7
Secondary	packed red blood cells transfused	Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO	Hour 48, Day 7
Secondary	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

External Links

•   Statistical analysis plan