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Trial record 1 of 1 for:    NCT02754193
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Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO) (HYPO-ECMO)

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ClinicalTrials.gov Identifier: NCT02754193
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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).


Condition or disease Intervention/treatment Phase
Cardiogenic Shock Other: moderate hypothermia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
Actual Study Start Date : October 10, 2016
Actual Primary Completion Date : July 28, 2019
Actual Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia Shock

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
Other: 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.

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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754193


Locations
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Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02754193    
Other Study ID Numbers: 2016-A00377-44
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Central Hospital, Nancy, France:
Venous-Arterial ExtraCorporeal Membrane Oxygenation
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Hypothermia
Pathologic Processes
Body Temperature Changes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Infarction
Ischemia
Necrosis