Efficacy and Safety of TTM in Adults With ECPR. (TTM、ECPR)

September 23, 2024 updated by: Qingbian Ma, MD, Peking University Third Hospital

A Multicenter, Single-Blind Randomized Controlled Trial of TTM(Target Temperature Management) in Adults With ECPR(Extracorporeal Cardiopulmonary Resuscitation)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Emergency Dept of Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hypothermia group
Combined target temperature management (TTM) in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and with a target temperature control of 34°C.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day survival outcomes
Time Frame: 30 days after randomization
All-cause survival rate of patients on day 30 after randomization.
30 days after randomization
30-day neurologic function outcomes
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.
30 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prolong follow-up survival outcome
Time Frame: 90 days and 6 months after randomization
survival rate
90 days and 6 months after randomization
prolong follow-up neurologic outcome
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.
30 days, 3 months, and 6 months after randomization
Incidence of any bleeding, infection, arrhythmia, acute kidney injury and seizure [Safety and Tolerability]
Time Frame: 30 days after randomization
30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006761-M2022581

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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