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

May 5, 2021 updated by: Central Hospital, Nancy, France

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France
        • CHU Amiens - Picardie -Site sud
      • Annecy, France
        • CH Annecy Centre Hospitalier
      • Besancon, France
        • CHU Besancon Hopital Jean Minjoz
      • Bordeaux, France
        • CHU Bordeaux - Groupe Hospitalier SaintAndré
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand -Hopital G. Montpied
      • Grenoble, France
        • CHU Grenoble
      • Lyon, France
        • CHU Lyon - Hôpital Louis Pradel
      • Marseille, France
        • APHM-Hôpital, de la Timone
      • Montpellier, France
        • CHU Montpellier
      • Nantes, France
        • CHU Nantes/ Hôpital Nord Laennec
      • Paris, France
        • APHP-HEGP
      • Paris, France
        • APHP- Hopital BICHAT
      • Paris, France
        • APHP- la Pitié Sapêtrière
      • Paris, France
        • APHP-Pitié
      • Rennes, France
        • Chu Rennes Hopital Pontchaillou
      • Rouen, France
        • CHU Rouen
      • Strasbourg, France
        • CHRU Strasbourg
      • Strasbourg, France
        • CHU Strasbourg/ NHC
      • Toulouse, France
        • CHU Toulouse Hôpital - Pierre Paul Riquet
      • Vandoeuvre les Nancy, France
        • CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
No Intervention: Normothermia
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: 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
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Hour 48, Day 7, Day 60, day 180
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
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time
up to 180 days (from date of randomization until ECMO weaning)
Death
Time Frame: 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)
day 30, Day 60, Day 180
cardiac transplant
Time Frame: 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)
day 30, Day 60, Day 180
escalation to Left Ventricular Assist Device
Time Frame: 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)
day 30, Day 60, Day180
Stroke
Time Frame: 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)
Day 30, Day 60, Day 180
Cumulated amount of administered fluids
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
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
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
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
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
Evaluation of the impact of moderate hypothermia on lactate clearance
up to 180 days (from date of randomization until ECMO weaning)
SOFA score
Time Frame: from baseline until Day 30
Evaluation of the impact of moderate hypothermia on duration of organ failure
from baseline until Day 30
Mechanical ventilation
Time Frame: baseline, day 30, day 60 and day 180
Evaluation of the impact of moderate hypothermia on mechanical ventilation support use
baseline, day 30, day 60 and day 180
Renal replacement therapy
Time Frame: from baseline until day 30, day 60, day 180
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
Time Frame: Day 30; Day 60; Day 180
Evaluation of the impact of moderate hypothermia on duration of ICU stay
Day 30; Day 60; Day 180
hospitalization stay
Time Frame: Day 30; Day 60; Day 180
Evaluation of the impact of moderate hypothermia on duration of total hospitalization
Day 30; Day 60; Day 180
bleeding complications
Time Frame: Hour 48, Day 7
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
Hour 48, Day 7
packed red blood cells transfused
Time Frame: Hour 48, Day 7
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
Hour 48, Day 7
Infection
Time Frame: 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)
Hour 48, Day 7, Day 30, Day 60, day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Nicolas GIRERD, Pr, CHRU Nancy
  • Study Chair: Patrick ROSSIGNOL, Pr, CHRU Nancy
  • Principal Investigator: Bruno LEVY, Pr, CHRU Nancy
  • Study Chair: Alain COMBES, Pr, APHP-Pitié Salpêtrière
  • Study Chair: Fabrice VANHUYSE, Dr, CHRU Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2016

Primary Completion (Actual)

July 28, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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