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Effects of cooling duration on recovery in cardiac arrest patients

Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients - A Multicenter, Randomized, Adaptive Clinical Trial to Identify the Optimal Duration of Induced Hypothermia for Neuroprotection in Comatose Survivors of Cardiac Arrest

Not applicable Interventional University of Michigan · NCT04217551

This study is testing if cooling patients who have survived a cardiac arrest for different lengths of time can help them recover better and improve their brain function.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1800 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Michigan Academic / other
Locations77 sites (Birmingham, Alabama and 76 other locations)
Trial IDNCT04217551 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized clinical trial investigates the impact of varying durations of induced hypothermia on neurological outcomes in comatose survivors of out-of-hospital cardiac arrest. The study aims to determine if longer cooling durations correlate with improved recovery rates and to identify the optimal cooling duration for neuroprotection. Participants will be cooled to below 34 degrees Celsius within 240 minutes of cardiac arrest, with careful monitoring and adaptive allocation of treatment based on outcomes. The trial seeks to enhance strategies for improving neurological recovery in this critical patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are comatose after resuscitation from out-of-hospital cardiac arrest and can be cooled within the specified time frame.

Not a fit: Patients with hemodynamic instability, pre-existing neurological disabilities, or those who are unlikely to survive to outcome determination may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly increase the rate of good neurological outcomes in patients who have suffered cardiac arrest.

How similar studies have performed: Previous studies have shown that therapeutic hypothermia can improve neurological outcomes, but this specific approach to varying cooling durations is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Coma after resuscitation from out of hospital cardiac arrest
* Cooled to \<34 deg C with 240 minutes of cardiac arrest
* Definitive temperature control applied
* Age ≥ 18 years
* Informed consent from legal authorized representative (LAR) including intent to maintain life support for 96 hours
* Enrollment within 6 hours of initiation of cooling

Exclusion Criteria:

* Hemodynamic instability
* Pre-existing neurological disability or condition that confounds outcome determination
* Pre-existing terminal illness, unlikely to survive to outcome determination
* Planned early withdrawal of life support
* Presumed sepsis as etiology of arrest
* Prisoner

Where this trial is running

Birmingham, Alabama and 76 other locations

+27 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, BrainBayesian Adaptive Clinical TrialHypothermia, therapeuticComa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.