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Cardiogenic ShockHYPO-ECMONCT02754193

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

A study testing moderate hypothermia in people with Cardiogenic Shock, run by Central Hospital, Nancy, France at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock
What is being tested?
moderate hypothermia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
20 sitesFrance
Study dates
10 Oct 2016to 13 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Intubated patients with cardiogenic shock treated with VA-ECMO
  • Patient affiliated to social security plan

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • CHU Amiens - Picardie -Site sud

    Amiens

  • CH Annecy Centre Hospitalier

    Annecy

  • CHU Besançon Hôpital Jean Minjoz

    Besançon

  • CHU Bordeaux - Groupe Hospitalier SaintAndré

    Bordeaux

  • CHU Clermont-Ferrand -Hopital G. Montpied

    Clermont-Ferrand

  • CHU Grenoble

    Grenoble

  • CHU Lyon - Hôpital Louis Pradel

    Lyon

  • APHM-Hôpital, de la Timone

    Marseille

  • CHU Montpellier

    Montpellier

  • CHU Nantes/ Hôpital Nord Laennec

    Nantes

  • APHP- Hôpital Bichat

    Paris

  • APHP- la Pitié Sapêtrière

    Paris

  • Aphp-Hegp

    Paris

  • APHP-Pitié

    Paris

  • CHU Rennes Hôpital Pontchaillou

    Rennes

  • Chu Rouen

    Rouen

  • CHRU Strasbourg

    Strasbourg

  • CHU Strasbourg/ NHC

    Strasbourg

  • CHU Toulouse Hôpital - Pierre Paul Riquet

    Toulouse

  • CHRU Nancy

    Vandœuvre-lès-Nancy

Other trials in France

About this study

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).

Being tested
moderate hypothermia
Keywords
Venous-Arterial ExtraCorporeal Membrane Oxygenation
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • moderate hypothermiaOther

    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.

Study groups in NCT02754193
Study groupRoleWhat they receive
Moderate hypothermiaExperimentalModerate 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
Receives: Other: moderate hypothermia
NormothermiaNo interventionNormothermia: 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 30

Secondary outcomes (17)

  1. All-cause mortality

    Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days

    Measured: Hour 48, Day 7, Day 60, day 180

  2. Venous Arterial ECMO duration

    Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time

    Measured: up to 180 days (from date of randomization until ECMO weaning)

  3. 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)

    Measured: day 30, Day 60, Day 180

  4. 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)

    Measured: day 30, Day 60, Day 180

  5. 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)

    Measured: day 30, Day 60, Day180

  6. 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)

    Measured: Day 30, Day 60, Day 180

  7. Cumulated amount of administered fluids

    Evaluation of the impact of moderate hypothermia on necessity of fluid

    Measured: up to 180 days (from date of randomization until ECMO weaning)

  8. Cumulated amount of vasopressors use

    Evaluation of the impact of moderate hypothermia on necessity of vasopressor (norepinephrine, epinephrine)

    Measured: up to 180 days (from date of randomization until ECMO weaning)

  9. Lactate

    Evaluation of the impact of moderate hypothermia on lactate clearance

    Measured: up to 180 days (from date of randomization until ECMO weaning)

  10. SOFA score

    Evaluation of the impact of moderate hypothermia on duration of organ failure

    Measured: from baseline until Day 30

  11. Mechanical ventilation

    Evaluation of the impact of moderate hypothermia on mechanical ventilation support use

    Measured: baseline, day 30, day 60 and day 180

  12. Renal replacement therapy

    Evaluation of the impact of moderate hypothermia on renal replacement therapy use

    Measured: from baseline until day 30, day 60, day 180

  13. Intensive care unit stay

    Evaluation of the impact of moderate hypothermia on duration of ICU stay

    Measured: Day 30; Day 60; Day 180

  14. hospitalization stay

    Evaluation of the impact of moderate hypothermia on duration of total hospitalization

    Measured: Day 30; Day 60; Day 180

  15. bleeding complications

    Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO

    Measured: Hour 48, Day 7

  16. packed red blood cells transfused

    Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO

    Measured: Hour 48, Day 7

  17. Infection

    Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes)

    Measured: Hour 48, Day 7, Day 30, Day 60, day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2016 (estimated)
  2. Study start10 Oct 2016
  3. Primary completion28 Jul 2019
  4. Study completion13 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02754193
Sponsor's protocol ID
2016-A00377-44
Acronym
HYPO-ECMO
Status last verified
Mar 2021
First submitted
12 Apr 2016
Last updated
7 May 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40390595

  • 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.

    PubMed 40023081

  • 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.

    PubMed 38536534

  • 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.

    PubMed 35103766

  • 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.

    PubMed 31615800

Questions about this trial

What is this clinical trial studying?

A study testing moderate hypothermia in people with Cardiogenic Shock, run by Central Hospital, Nancy, France at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02754193, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.

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