Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 9:27 PM
Study NCT ID:
NCT02754193
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPO-ECMO
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: