Efficacy and Safety of TTM in Adults With ECPR. (TTM、ECPR)

Peking University

Status: Active, not recruiting

Conditions: Cardiac Arrest

Treatments: Behavioral: normothermia group; Behavioral: hypothermia group

Study type: Interventional

Funder types: Other

Identifiers

NCT06608095

IRB00006761-M2022581

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged ≥18 and ≤60 years;
2. Patients with in-hospital and out-of-hospital cardiac arrest of any initial rhythm;
3. Patients who have received cardiopulmonary resuscitation for >10 minutes without achieving return of spontaneous circulation;
4. Patients with a reversible cause of cardiac arrest (acute myocardial infarction, pulmonary embolism, all initial defibrillatable rhythm, cardiomyopathy);

Exclusion criteria

1. cardiac arrest due to trauma;
2. pregnant and lactating women;
3. unwitnessed cardiac arrest;
4. out-of-hospital cardiac arrest not receiving CPR within 5 minutes;
5. > 60 minutes from the onset of cardiac arrest to the initiation of extracorporeal cardiopulmonary resuscitation;
6. achievement of return of spontaneous circulation before the start of external cardiopulmonary resuscitation;
7. intracranial hemorrhage or suspected intracranial hemorrhage;
8. pre-existing neurologic impairment (CPC ≥ 3) prior to the onset of cardiac arrest;
9. those with end-stage heart failure;
10. those with new-onset cerebral hemorrhage or cerebral infarction;
11. other vascular conditions such as severe plaque in bilateral femoral arteries that cause difficulty in tube placement;
12. patients with combined malignant tumors;
13. other serious diseases with a life expectancy of <1 year;
14. refusal to perform extracorporeal cardiopulmonary resuscitation and/or target temperature administrators.
15. Temperature <30°C.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

hypothermia group

Experimental group

Description:

Combined target temperature management (TTM) in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and with a target temperature control of 34°C.

Treatment:

Behavioral: hypothermia group

normothermia group

Experimental group

Description:

Combined target temperature management (TTM) in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and with a target temperature control of 36.5-37.2°C.

Treatment:

Behavioral: normothermia group