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Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

NCT04217551 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1158

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

  • Cardiac Arrest, Out-Of-Hospital
  • Hypothermia, Induced
  • Hypoxia-Ischemia, Brain

Interventions

DEVICE

Therapeutic Hypothermia

Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • William Meurer · University of Michigan

  • Robert Silbergleit · University of Michigan

  • Romer Geocadin · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2025-09-05
Completion
2025-09-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04217551 on ClinicalTrials.gov