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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)

Primary Purpose

Cardiogenic Shock

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
moderate hypothermia
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Venous-Arterial ExtraCorporeal Membrane Oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens - Picardie -Site sud
  • CH Annecy Centre Hospitalier
  • CHU Besançon Hôpital Jean Minjoz
  • CHU Bordeaux - Groupe Hospitalier SaintAndré
  • CHU Clermont-Ferrand -Hopital G. Montpied
  • CHU Grenoble
  • CHU Lyon - Hôpital Louis Pradel
  • APHM-Hôpital, de la Timone
  • CHU Montpellier
  • CHU Nantes/ Hôpital Nord Laennec
  • APHP- Hôpital Bichat
  • APHP- la Pitié Sapêtrière
  • Aphp-Hegp
  • APHP-Pitié
  • CHU Rennes Hôpital Pontchaillou
  • Chu Rouen
  • CHRU Strasbourg
  • CHU Strasbourg/ NHC
  • CHU Toulouse Hôpital - Pierre Paul Riquet
  • CHRU Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Moderate hypothermia

Normothermia

Arm Description

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

Normothermia: Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of normothermia (36°C≤ T°C ≤37°C) associated with usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause mortality
Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days
Venous Arterial ECMO duration
Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time
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)
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)
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)
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)
Cumulated amount of administered fluids
Evaluation of the impact of moderate hypothermia on necessity of fluid
Cumulated amount of vasopressors use
Evaluation of the impact of moderate hypothermia on necessity of vasopressor (norepinephrine, epinephrine)
Lactate
Evaluation of the impact of moderate hypothermia on lactate clearance
SOFA score
Evaluation of the impact of moderate hypothermia on duration of organ failure
Mechanical ventilation
Evaluation of the impact of moderate hypothermia on mechanical ventilation support use
Renal replacement therapy
Evaluation of the impact of moderate hypothermia on renal replacement therapy use
Intensive care unit stay
Evaluation of the impact of moderate hypothermia on duration of ICU stay
hospitalization stay
Evaluation of the impact of moderate hypothermia on duration of total hospitalization
bleeding complications
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
packed red blood cells transfused
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
Infection
Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes)

Full Information

First Posted
April 12, 2016
Last Updated
May 5, 2021
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02754193
Brief Title
Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
Acronym
HYPO-ECMO
Official Title
Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
July 28, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
Venous-Arterial ExtraCorporeal Membrane Oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate hypothermia
Arm Type
Experimental
Arm Description
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
Arm Title
Normothermia
Arm Type
No Intervention
Arm Description
Normothermia: Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of normothermia (36°C≤ T°C ≤37°C) associated with usual care
Intervention Type
Other
Intervention Name(s)
moderate hypothermia
Intervention Description
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 Outcome Measure Information:
Title
All-cause Mortality
Description
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
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days
Time Frame
Hour 48, Day 7, Day 60, day 180
Title
Venous Arterial ECMO duration
Description
Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time
Time Frame
up to 180 days (from date of randomization until ECMO weaning)
Title
Death
Description
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)
Time Frame
day 30, Day 60, Day 180
Title
cardiac transplant
Description
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)
Time Frame
day 30, Day 60, Day 180
Title
escalation to Left Ventricular Assist Device
Description
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)
Time Frame
day 30, Day 60, Day180
Title
Stroke
Description
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)
Time Frame
Day 30, Day 60, Day 180
Title
Cumulated amount of administered fluids
Description
Evaluation of the impact of moderate hypothermia on necessity of fluid
Time Frame
up to 180 days (from date of randomization until ECMO weaning)
Title
Cumulated amount of vasopressors use
Description
Evaluation of the impact of moderate hypothermia on necessity of vasopressor (norepinephrine, epinephrine)
Time Frame
up to 180 days (from date of randomization until ECMO weaning)
Title
Lactate
Description
Evaluation of the impact of moderate hypothermia on lactate clearance
Time Frame
up to 180 days (from date of randomization until ECMO weaning)
Title
SOFA score
Description
Evaluation of the impact of moderate hypothermia on duration of organ failure
Time Frame
from baseline until Day 30
Title
Mechanical ventilation
Description
Evaluation of the impact of moderate hypothermia on mechanical ventilation support use
Time Frame
baseline, day 30, day 60 and day 180
Title
Renal replacement therapy
Description
Evaluation of the impact of moderate hypothermia on renal replacement therapy use
Time Frame
from baseline until day 30, day 60, day 180
Title
Intensive care unit stay
Description
Evaluation of the impact of moderate hypothermia on duration of ICU stay
Time Frame
Day 30; Day 60; Day 180
Title
hospitalization stay
Description
Evaluation of the impact of moderate hypothermia on duration of total hospitalization
Time Frame
Day 30; Day 60; Day 180
Title
bleeding complications
Description
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
Time Frame
Hour 48, Day 7
Title
packed red blood cells transfused
Description
Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO
Time Frame
Hour 48, Day 7
Title
Infection
Description
Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes)
Time Frame
Hour 48, Day 7, Day 30, Day 60, day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno LEVY, Pr
Organizational Affiliation
CHRU Nancy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain COMBES, Pr
Organizational Affiliation
APHP-Pitié Salpêtrière
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabrice VANHUYSE, Dr
Organizational Affiliation
CHRU Nancy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, Pr
Organizational Affiliation
CHRU Nancy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick ROSSIGNOL, Pr
Organizational Affiliation
CHRU Nancy
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Amiens - Picardie -Site sud
City
Amiens
Country
France
Facility Name
CH Annecy Centre Hospitalier
City
Annecy
Country
France
Facility Name
CHU Besançon Hôpital Jean Minjoz
City
Besancon
Country
France
Facility Name
CHU Bordeaux - Groupe Hospitalier SaintAndré
City
Bordeaux
Country
France
Facility Name
CHU Clermont-Ferrand -Hopital G. Montpied
City
Clermont-Ferrand
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
CHU Lyon - Hôpital Louis Pradel
City
Lyon
Country
France
Facility Name
APHM-Hôpital, de la Timone
City
Marseille
Country
France
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Facility Name
CHU Nantes/ Hôpital Nord Laennec
City
Nantes
Country
France
Facility Name
APHP- Hôpital Bichat
City
Paris
Country
France
Facility Name
APHP- la Pitié Sapêtrière
City
Paris
Country
France
Facility Name
Aphp-Hegp
City
Paris
Country
France
Facility Name
APHP-Pitié
City
Paris
Country
France
Facility Name
CHU Rennes Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
Chu Rouen
City
Rouen
Country
France
Facility Name
CHRU Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU Strasbourg/ NHC
City
Strasbourg
Country
France
Facility Name
CHU Toulouse Hôpital - Pierre Paul Riquet
City
Toulouse
Country
France
Facility Name
CHRU Nancy
City
Vandoeuvre les Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35103766
Citation
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. Erratum In: JAMA. 2023 Apr 11;329(14):1226.
Results Reference
derived
PubMed Identifier
31615800
Citation
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.
Results Reference
derived
Links:
URL
https://cic-p-nancy.fr/wp-content/uploads/2021/01/HYPO-ECMO-SAP-2021.pdf
Description
Statistical analysis plan

Learn more about this trial

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

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