Efficacy and Safety of TTM in Adults With ECPR.

NCT06608095 | Active Not Recruiting DMC

• 1 other identifier: IRB00006761-M2022581
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

cardiac arrest; extracorporeal cardiopulmonary resuscitation; hypothermia; normothermia; clinical outcome; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 30-day survival outcomes

  All-cause survival rate of patients on day 30 after randomization.

  30 days after randomization

• 30-day neurologic function outcomes

  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.

  30 days after randomization

Secondary Outcomes (3)

• prolong follow-up survival outcome

  90 days and 6 months after randomization

• prolong follow-up neurologic outcome

  30 days, 3 months, and 6 months after randomization

• Incidence of any bleeding, infection, arrhythmia, acute kidney injury and seizure [Safety and Tolerability]

  30 days after randomization

Study Arms (2)

hypothermia group

EXPERIMENTAL

Combined target temperature management (TTM) in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and with a target temperature control of 34°C.

Behavioral: hypothermia group

normothermia group

EXPERIMENTAL

Combined target temperature management (TTM) in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and with a target temperature control of 36.5-37.2°C.

Behavioral: normothermia group

Interventions

hypothermia group BEHAVIORAL

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.

hypothermia group

normothermia group BEHAVIORAL

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.

normothermia group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged ≥18 and ≤60 years;
• Patients with in-hospital and out-of-hospital cardiac arrest of any initial rhythm;
• Patients who have received cardiopulmonary resuscitation for \>10 minutes without achieving return of spontaneous circulation;
• Patients with a reversible cause of cardiac arrest (acute myocardial infarction, pulmonary embolism, all initial defibrillatable rhythm, cardiomyopathy);

You may not qualify if:

• cardiac arrest due to trauma;
• pregnant and lactating women;
• unwitnessed cardiac arrest;
• out-of-hospital cardiac arrest not receiving CPR within 5 minutes;
• \> 60 minutes from the onset of cardiac arrest to the initiation of extracorporeal cardiopulmonary resuscitation;
• achievement of return of spontaneous circulation before the start of external cardiopulmonary resuscitation;
• intracranial hemorrhage or suspected intracranial hemorrhage;
• pre-existing neurologic impairment (CPC ≥ 3) prior to the onset of cardiac arrest;
• those with end-stage heart failure;
• those with new-onset cerebral hemorrhage or cerebral infarction;
• other vascular conditions such as severe plaque in bilateral femoral arteries that cause difficulty in tube placement;
• patients with combined malignant tumors;
• other serious diseases with a life expectancy of \<1 year;
• refusal to perform extracorporeal cardiopulmonary resuscitation and/or target temperature administrators.
• Temperature \<30°C.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Emergency Dept of Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Emergency Department, Peking University Third Hospital

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: September 23, 2024
• Study Start: November 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CN (1)