Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
HYPO-ECMO
1 other identifier
interventional
334
1 country
20
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Typical duration for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
October 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2019
CompletedMay 7, 2021
March 1, 2021
2.8 years
April 12, 2016
May 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
All-cause mortality
Hour 48, Day 7, Day 60, day 180
Venous Arterial ECMO duration
up to 180 days (from date of randomization until ECMO weaning)
Death
day 30, Day 60, Day 180
cardiac transplant
day 30, Day 60, Day 180
escalation to Left Ventricular Assist Device
day 30, Day 60, Day180
- +12 more secondary outcomes
Study Arms (2)
Moderate hypothermia
EXPERIMENTALModerate 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
Normothermia
NO INTERVENTIONNormothermia: Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of normothermia (36°C≤ T°C ≤37°C) associated with usual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Intubated patients with cardiogenic shock treated with VA-ECMO
- Patient affiliated to social security plan
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
CHU Amiens - Picardie -Site sud
Amiens, France
CH Annecy Centre Hospitalier
Annecy, France
CHU Besançon Hôpital Jean Minjoz
Besançon, 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
Vandœuvre-lès-Nancy, France
Related Publications (5)
Baudry G, Girerd N, Duarte K, Monzo L, Delmas C, Van Spall HGC, Kimmoun A, Levy B. Sex-Related Prognosis of VA-ECMO-Treated Cardiogenic Shock: A Post Hoc Analysis of the HYPO-ECMO Trial. Circ Heart Fail. 2025 Aug;18(8):e012702. doi: 10.1161/CIRCHEARTFAILURE.124.012702. Epub 2025 May 20.
PMID: 40390595DERIVEDBaudry G, Levy B, Duarte K, Monzo L, Combes A, Kimmoun A, Girerd N. Prognosis of refractory cardiogenic shock in de-novo versus acute-on-chronic heart failure: Insights from the HYPO-ECMO trial. J Crit Care. 2025 Jun;87:155043. doi: 10.1016/j.jcrc.2025.155043. Epub 2025 Feb 28.
PMID: 40023081DERIVEDLevy B, Girerd N, Baudry G, Duarte K, Cuau S, Bakker J, Kimmoun A; HYPO-ECMO trial group and the International ECMO Network (ECMONet). Serial daily lactate levels association with 30-day outcome in cardiogenic shock patients treated with VA-ECMO: a post-hoc analysis of the HYPO-ECMO study. Ann Intensive Care. 2024 Mar 27;14(1):43. doi: 10.1186/s13613-024-01266-6.
PMID: 38536534DERIVEDLevy 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.
PMID: 35103766DERIVEDJacquot 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.
PMID: 31615800DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno LEVY, Pr
CHRU Nancy
- STUDY CHAIR
Alain COMBES, Pr
APHP-Pitié Salpêtrière
- STUDY CHAIR
Fabrice VANHUYSE, Dr
CHRU Nancy
- STUDY CHAIR
Nicolas GIRERD, Pr
CHRU Nancy
- STUDY CHAIR
Patrick ROSSIGNOL, Pr
CHRU Nancy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 28, 2016
Study Start
October 10, 2016
Primary Completion
July 28, 2019
Study Completion
November 13, 2019
Last Updated
May 7, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share