Efficacy and Safety of TTM in Adults With ECPR.

NCT06608095 · tracked via the Priya Life Science China tracker

Sponsor

Peking University Third Hospital

Phase

Not applicable

Started

2023-11-01

Last updated

2024-09-25

Condition(s) studied

Cardiac Arrest

Investigational drug(s) / intervention(s)

hypothermia groupnormothermia group

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.

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

60 Years

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Emergency Dept of Peking University Third Hospital	Beijing	Beijing Municipality

More Peking University Third Hospital trials in China

Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease. Recruiting

Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors Recruiting

Comparison of MBR + Suture Tape, MBR, and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study Recruiting

Position-Directed Budesonide Nasal Drops for CRS-associated Olfactory Dysfunction Starting soon

Trigger Timing in Ovarian Stimulations Recruiting

Other trials for the same condition

China Extracorporeal Life Support Registry Recruiting

Target-directed Management of Cerebral Oxygenation in Patients After Receiving ECPR Recruiting

The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients Active, not recruiting

Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest Recruiting

Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06608095 on ClinicalTrials.gov ↗ ← All trials in China