Active — Not RecruitingNot Applicable

Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

United States1,158 participantsStarted 2020-05-18

Plain-language summary

A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Weighted Modified Rankin Scale (mRS)

Timeframe: 90 days after return of spontaneous circulation

Trial details

NCT IDNCT04217551

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-05

View on ClinicalTrials.gov More Cardiac Arrest, Out-Of-Hospital trials