Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
NCT ID: NCT02754193
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
334 participants
INTERVENTIONAL
2016-10-10
2019-11-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
NCT02722473
Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm
NCT01994772
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
NCT00329563
Targeted Temperature Management at 33°C Versus Controlled Normothermia for In-hospital Cardiac Arrest
NCT07086703
IL Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
NCT02711098
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Intubated patients with cardiogenic shock treated with VA-ECMO
* Patient affiliated to social security plan
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Central Hospital, Nancy, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruno LEVY, Pr
Role: PRINCIPAL_INVESTIGATOR
CHRU Nancy
Alain COMBES, Pr
Role: STUDY_CHAIR
APHP-Pitié Salpêtrière
Fabrice VANHUYSE, Dr
Role: STUDY_CHAIR
CHRU Nancy
Nicolas GIRERD, Pr
Role: STUDY_CHAIR
CHRU Nancy
Patrick ROSSIGNOL, Pr
Role: STUDY_CHAIR
CHRU Nancy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Baudry 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.
Levy 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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Statistical analysis plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-A00377-44
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.