Clinical trial NCT02754193: Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Venous-Arterial ExtraCorporeal Membrane Oxygenation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: All-cause Mortality
timeFrame: Day 30
Secondary outcomes:
measure: All-cause mortality
timeFrame: Hour 48, Day 7, Day 60, day 180
measure: Venous Arterial ECMO duration
timeFrame: up to 180 days (from date of randomization until ECMO weaning)
measure: Death
timeFrame: day 30, Day 60, Day 180
measure: cardiac transplant
timeFrame: day 30, Day 60, Day 180
measure: escalation to Left Ventricular Assist Device
timeFrame: day 30, Day 60, Day180
measure: Stroke
timeFrame: Day 30, Day 60, Day 180
measure: Cumulated amount of administered fluids
timeFrame: up to 180 days (from date of randomization until ECMO weaning)
measure: Cumulated amount of vasopressors use
timeFrame: up to 180 days (from date of randomization until ECMO weaning)
measure: Lactate
timeFrame: up to 180 days (from date of randomization until ECMO weaning)
measure: SOFA score
timeFrame: from baseline until Day 30
measure: Mechanical ventilation
timeFrame: baseline, day 30, day 60 and day 180
measure: Renal replacement therapy
timeFrame: from baseline until day 30, day 60, day 180
measure: Intensive care unit stay
timeFrame: Day 30; Day 60; Day 180
measure: hospitalization stay
timeFrame: Day 30; Day 60; Day 180
measure: bleeding complications
timeFrame: Hour 48, Day 7
measure: packed red blood cells transfused
timeFrame: Hour 48, Day 7
measure: Infection
timeFrame: Hour 48, Day 7, Day 30, Day 60, day 180
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens - Picardie -Site sud
city: Annecy
country: France
facility: CH Annecy Centre Hospitalier
city: Besancon
country: France
facility: CHU Besançon Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU Bordeaux - Groupe Hospitalier SaintAndré
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand -Hopital G. Montpied
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: CHU Lyon - Hôpital Louis Pradel
city: Marseille
country: France
facility: APHM-Hôpital, de la Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes/ Hôpital Nord Laennec
city: Paris
country: France
facility: APHP- Hôpital Bichat
city: Paris
country: France
facility: APHP- la Pitié Sapêtrière
city: Paris
country: France
facility: Aphp-Hegp
city: Paris
country: France
facility: APHP-Pitié
city: Rennes
country: France
facility: CHU Rennes Hôpital Pontchaillou
city: Rouen
country: France
facility: Chu Rouen
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Strasbourg
country: France
facility: CHU Strasbourg/ NHC
city: Toulouse
country: France
facility: CHU Toulouse Hôpital - Pierre Paul Riquet
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Bruno LEVY, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP-Pitié Salpêtrière
name: Alain COMBES, Pr
role: STUDY_CHAIR
affiliation: CHRU Nancy
name: Fabrice VANHUYSE, Dr
role: STUDY_CHAIR
affiliation: CHRU Nancy
name: Nicolas GIRERD, Pr
role: STUDY_CHAIR
affiliation: CHRU Nancy
name: Patrick ROSSIGNOL, Pr
role: STUDY_CHAIR
References:
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.
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.