NCT02754193

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-10
• Primary completion: 2019-07-28
• Completion: 2019-11-13
• First posted: 2016-04-28
• Last updated: 2021-05-07

Locations

20 sites across 1 country: France