Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

Condition
Cardiac Arrest, Out-Of-Hospital
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Hospital, Birmingham, Alabama, United States, 35233

Tucson

Banner University Medical Center, Tucson, Arizona, United States, 85719

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

Ronald Regan UCLA Medical Center, Los Angeles, California, United States, 90095

Sacramento

UC Davis Medical Center, Sacramento, California, United States, 95817

San Diego

UC San Diego Medical Center - Hillcrest, San Diego, California, United States, 92103

San Francisco

Zuckerberg San Francisco General Hospital, San Francisco, California, United States, 94110

Stanford

Stanford University Medical Center, Stanford, California, United States, 94305

Torrance

Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Aurora

University of Colorado Hospital, Aurora, Colorado, United States, 80045

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

William Meurer, PRINCIPAL_INVESTIGATOR, University of Michigan

Robert Silbergleit, PRINCIPAL_INVESTIGATOR, University of Michigan

Romer Geocadin, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2028-08-31