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Completed

NCT Number: NCT02754193

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

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens - Picardie -Site sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moderate hypothermia

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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)

  9. Lactate

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

    Evaluation of the impact of moderate hypothermia on lactate clearance

  10. SOFA score

    Time frame: from baseline until Day 30

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

  11. Mechanical ventilation

    Time frame: baseline, day 30, day 60 and day 180

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

  12. 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

  13. Intensive care unit stay

    Time frame: Day 30; Day 60; Day 180

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

  14. hospitalization stay

    Time frame: Day 30; Day 60; Day 180

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

  15. bleeding complications

    Time frame: Hour 48, Day 7

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

  16. 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

  17. 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)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: HYPO-ECMO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2016
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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