- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02754193
Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO) (HYPO-ECMO)
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amiens, France
- CHU Amiens - Picardie -Site sud
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Annecy, France
- CH Annecy Centre Hospitalier
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Besancon, France
- CHU Besancon Hopital Jean Minjoz
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Bordeaux, France
- CHU Bordeaux - Groupe Hospitalier SaintAndré
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Clermont-Ferrand, France
- CHU Clermont-Ferrand -Hopital G. Montpied
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Grenoble, France
- CHU Grenoble
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Lyon, France
- CHU Lyon - Hôpital Louis Pradel
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Marseille, France
- APHM-Hôpital, de la Timone
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Montpellier, France
- CHU Montpellier
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Nantes, France
- CHU Nantes/ Hôpital Nord Laennec
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Paris, France
- APHP-HEGP
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Paris, France
- APHP- Hopital BICHAT
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Paris, France
- APHP- la Pitié Sapêtrière
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Paris, France
- APHP-Pitié
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Rennes, France
- Chu Rennes Hopital Pontchaillou
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Rouen, France
- CHU Rouen
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Strasbourg, France
- CHRU Strasbourg
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Strasbourg, France
- CHU Strasbourg/ NHC
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Toulouse, France
- CHU Toulouse Hôpital - Pierre Paul Riquet
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Vandoeuvre les Nancy, France
- CHRU Nancy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause Mortality
Time Frame: Day 30
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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
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Day 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: Hour 48, Day 7, Day 60, day 180
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Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days
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Hour 48, Day 7, Day 60, day 180
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Venous Arterial ECMO duration
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
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Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time
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up to 180 days (from date of randomization until ECMO weaning)
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Death
Time Frame: day 30, Day 60, Day 180
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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)
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day 30, Day 60, Day 180
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cardiac transplant
Time Frame: day 30, Day 60, Day 180
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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)
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day 30, Day 60, Day 180
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escalation to Left Ventricular Assist Device
Time Frame: day 30, Day 60, Day180
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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)
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day 30, Day 60, Day180
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Stroke
Time Frame: Day 30, Day 60, Day 180
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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)
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Day 30, Day 60, Day 180
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Cumulated amount of administered fluids
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
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Evaluation of the impact of moderate hypothermia on necessity of fluid
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up to 180 days (from date of randomization until ECMO weaning)
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Cumulated amount of vasopressors use
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
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Evaluation of the impact of moderate hypothermia on necessity of vasopressor (norepinephrine, epinephrine)
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up to 180 days (from date of randomization until ECMO weaning)
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Lactate
Time Frame: up to 180 days (from date of randomization until ECMO weaning)
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Evaluation of the impact of moderate hypothermia on lactate clearance
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up to 180 days (from date of randomization until ECMO weaning)
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SOFA score
Time Frame: from baseline until Day 30
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Evaluation of the impact of moderate hypothermia on duration of organ failure
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from baseline until Day 30
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Mechanical ventilation
Time Frame: baseline, day 30, day 60 and day 180
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Evaluation of the impact of moderate hypothermia on mechanical ventilation support use
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baseline, day 30, day 60 and day 180
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Renal replacement therapy
Time Frame: from baseline until day 30, day 60, day 180
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Evaluation of the impact of moderate hypothermia on renal replacement therapy use
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from baseline until day 30, day 60, day 180
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Intensive care unit stay
Time Frame: Day 30; Day 60; Day 180
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Evaluation of the impact of moderate hypothermia on duration of ICU stay
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Day 30; Day 60; Day 180
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hospitalization stay
Time Frame: Day 30; Day 60; Day 180
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Evaluation of the impact of moderate hypothermia on duration of total hospitalization
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Day 30; Day 60; Day 180
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bleeding complications
Time Frame: Hour 48, Day 7
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Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
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Hour 48, Day 7
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packed red blood cells transfused
Time Frame: Hour 48, Day 7
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Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
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Hour 48, Day 7
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Infection
Time Frame: Hour 48, Day 7, Day 30, Day 60, day 180
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Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes)
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Hour 48, Day 7, Day 30, Day 60, day 180
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Collaborators and Investigators
Sponsor
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
General Publications
- Levy B, Girerd N, Amour J, Besnier E, Nesseler N, Helms J, Delmas C, Sonneville R, Guidon C, Rozec B, David H, Bougon D, Chaouch O, Walid O, Herve D, Belin N, Gaide-Chevronnay L, Rossignol P, Kimmoun A, Duarte K, Slutsky AS, Brodie D, Fellahi JL, Ouattara A, Combes A; HYPO-ECMO Trial Group and the International ECMO Network (ECMONet). Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):442-453. doi: 10.1001/jama.2021.24776.
- Jacquot A, Lepage X, Merckle L, Girerd N, Levy B. Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study). BMJ Open. 2019 Oct 14;9(10):e031697. doi: 10.1136/bmjopen-2019-031697.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A00377-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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