NCT06608095

Efficacy and Safety of TTM in Adults With ECPR.

A Multicenter, Single-Blind Randomized Controlled Trial of TTM(Target Temperature Management) in Adults With ECPR(Extracorporeal Cardiopulmonary Resuscitation)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Investigators hypothesize that there is a difference in the 30-day survival rate and good neurological outcome rate between two groups of cardiac arrest patients undergoing ECPR, one group receiving hypothermia and the other group receiving normothermia. Among the patients undergoing extracorporeal cardiopulmonary resuscitation, after screening with inclusion criteria as well as exclusion criteria, informed consent for the experiment was signed and randomly assigned into 2 groups. One group underwent extracorporeal cardiopulmonary resuscitation combined with hypothermia (34°C) and the other group underwent extracorporeal cardiopulmonary resuscitation combined with normothermia (36.5-37.5℃). Information related to the prognosis of the participants in both groups was obtained, evaluated statistically, and final conclusions were drawn.

Conditions

• Cardiac Arrest

Interventions

Type	Name	Description
BEHAVIORAL	hypothermia group	Minimize the temperature of the thermometric tank or thermometric catheter for rapid temperature control. Use a thermometric catheter to monitor changes in the patient's core body temperature in real time. When the core body temperature drops to 34 ℃, adjust the target temperature of the temperature-controlled water tank to 34 ℃ and adjust the target temperature of the temperature-controlled water tank in real time according to the patient's core body temperature. Keep the core body temperature around 34 ℃. Maintain the body temperature at 34℃ for at least 24 hours after the patient resumes autonomous circulation. After the patient has resumed voluntary circulation for 24 hours, the rewarming process can begin. The target temperature of the temperature control tank will increase at a rate of 0.2°C/h. After reaching 36°C, maintain the current temperature. Once 36°C is reached, the current temperature is maintained until autonomic circulation has been restored for 5 days.
BEHAVIORAL	normothermia group	Set the temperature of the temperature-controlled water tank or the in vivo cooling catheter to 37°C to maintain the patient's core temperature between 36.5-37.5°C. Real-time monitoring of the patient's core temperature changes through the thermometric urinary catheter, and real-time adjustment of the temperature of the temperature-controlled water tank. The patient's temperature was maintained between 36.5-37.5°C after the patient resumed voluntary circulation until the end of temperature control 5 days after the recovery of voluntary circulation.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2024-09-23
• Last updated: 2024-09-25

Locations

1 site across 1 country: China