Clinical trial NCT06608095: Efficacy and Safety of TTM in Adults With ECPR.
Official title: A Multicenter, Single-Blind Randomized Controlled Trial of TTM(Target Temperature Management) in Adults With ECPR(Extracorporeal Cardiopulmonary Resuscitation)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Keywords: cardiac arrest
extracorporeal cardiopulmonary resuscitation
hypothermia
normothermia
clinical outcome
randomized controlled trial
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 30-day survival outcomes
timeFrame: 30 days after randomization
measure: 30-day neurologic function outcomes
timeFrame: 30 days after randomization
Secondary outcomes:
measure: prolong follow-up survival outcome
timeFrame: 90 days and 6 months after randomization
measure: prolong follow-up neurologic outcome
timeFrame: 30 days, 3 months, and 6 months after randomization
measure: Incidence of any bleeding, infection, arrhythmia, acute kidney injury and seizure [Safety and Tolerability]
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Emergency Dept of Peking University Third Hospital
state: Beijing
Study officials:
References:
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