Emergency Dept of Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
NCT Number: NCT06608095
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100191, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 30 days after randomization
All-cause survival rate of patients on day 30 after randomization.
Time frame: 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.
Time frame: 90 days and 6 months after randomization
survival rate
Time frame: 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.
Time frame: 30 days after randomization
Peking University Third Hospital
Other
A Multicenter, Single-Blind Randomized Controlled Trial of TTM(Target Temperature Management) in Adults With ECPR(Extracorporeal Cardiopulmonary Resuscitation)
Acronym: TTM、ECPR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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