Efficacy and Safety of TTM in Adults With ECPR.

Not Applicable

Active, not recruiting

• Conditions: Cardiac Arrest
• Interventions: Behavioral: hypothermia group; Behavioral: normothermia group

• Registration Number: NCT06608095
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-10-20
• Study Start: 2023-11-01
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 146

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);

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypothermia group	hypothermia group	Combined target temperature management (TTM) in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and with a target temperature control of 34°C.
normothermia group	normothermia group	Combined target temperature management (TTM) in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and with a target temperature control of 36.5-37.2°C.

Primary Outcome Measures

Name	Time	Method
30-day survival outcomes	30 days after randomization	All-cause survival rate of patients on day 30 after randomization.
30-day neurologic function outcomes	30 days after randomization	Rate of patients with good neurological outcome at day 30 of randomization.Good neurological outcome is defined as a cerebral performance category(CPC) score of 1 or 2.

Secondary Outcome Measures

Name	Time	Method
prolong follow-up survival outcome	90 days and 6 months after randomization	survival rate
prolong follow-up neurologic outcome	30 days, 3 months, and 6 months after randomization	Modified Rankin scale neurologic function scores and cerebral performance category(CPC) scores at 30 days, 3 months, and 6 months after randomization.Modified Rankin scale neurologic function scores assesses the poststroke sequelae, ranges from 0 (no symptoms) to 6 (death), and establishes the patient's functional independence (from 0 to 2) or dependence (from 3 to 5).Cerebral performance category(CPC) scores define a good outcome as a CPC score of 1 or 2, and a poor outcome (severe neurological disability, persistent vegetative state or death) as CPC scores 3, 4, or 5.
Incidence of any bleeding, infection, arrhythmia, acute kidney injury and seizure [Safety and Tolerability]	30 days after randomization

Trial Locations

Locations (1)

Emergency Dept of Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China