Cardiac Arrest
Conditions
Keywords
cardiac arrest, extracorporeal cardiopulmonary resuscitation, hypothermia, normothermia, clinical outcome, randomized controlled trial
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.
Interventions
BEHAVIORALhypothermia 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.
BEHAVIORALnormothermia 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.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed