ACTIVE_NOT_RECRUITING

Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

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Conditions

Cardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, BrainBayesian Adaptive Clinical TrialHypothermia, therapeuticComa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-05-18
Study Completion:2025-09-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04217551

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Coma after resuscitation from out of hospital cardiac arrest
  2. * Cooled to \<34 deg C with 240 minutes of cardiac arrest
  3. * Definitive temperature control applied
  4. * Age ≥ 18 years
  5. * Informed consent from legal authorized representative (LAR) including intent to maintain life support for 96 hours
  6. * Enrollment within 6 hours of initiation of cooling
  1. * Hemodynamic instability
  2. * Pre-existing neurological disability or condition that confounds outcome determination
  3. * Pre-existing terminal illness, unlikely to survive to outcome determination
  4. * Planned early withdrawal of life support
  5. * Presumed sepsis as etiology of arrest
  6. * Prisoner

Contacts and Locations

Principal Investigator

William Meurer
PRINCIPAL_INVESTIGATOR
University of Michigan
Robert Silbergleit
PRINCIPAL_INVESTIGATOR
University of Michigan
Romer Geocadin
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

University of Alabama Hospital
Birmingham, Alabama, 35233
United States
Banner University Medical Center
Tucson, Arizona, 85719
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Ronald Regan UCLA Medical Center
Los Angeles, California, 90095
United States
UC Davis Medical Center
Sacramento, California, 95817
United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Harbor-UCLA Medical Center
Torrance, California, 90502
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
Denver Health Medical Center
Denver, Colorado, 80204
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
George Washington University Hospital
Washington, District of Columbia, 20037
United States
UF Health Shands Hospital
Gainesville, Florida, 32608
United States
Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
The Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois-Chicago Hosptial
Chicago, Illinois, 60612
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Kentucky Hospital
Lexington, Kentucky, 40536
United States
Maine Medical Center
Portland, Maine, 04102
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109
United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
United States
Detroit Receiving Hospital
Detroit, Michigan, 48201
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
DMC Sinai Grace Hospital
Detroit, Michigan, 48235
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
M Health Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
University of New Mexico
Albuquerque, New Mexico, 87106
United States
South Shore University Hospital
Bay Shore, New York, 11706
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
NYU Langone Health - Tisch Hospital
New York, New York, 10016
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
NYP Columbia University Medical Center
New York, New York, 10032
United States
Strong Memorial Hospital
Rochester, New York, 14642
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Duke University Hospital
Durham, North Carolina, 27710
United States
ECU Health Medical Center
Greenville, North Carolina, 27834
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
University of Cincinnati
Cincinnati, Ohio, 45220
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
OSU East Hospital
Columbus, Ohio, 43203
United States
OSU Wexner Medical Center
Columbus, Ohio, 43210
United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608
United States
Adventist Health
Portland, Oregon, 97216
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
UPMC Harrisburg
Harrisburg, Pennsylvania, 17101
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, 18840
United States
Parkland Hospital
Dallas, Texas, 75235
United States
Memorial Hermann Hospital
Houston, Texas, 77030
United States
University of Utah Hospital
Salt Lake City, Utah, 84132
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903
United States
VCU Medical Center
Richmond, Virginia, 23298
United States
Providence Regional Medical Center Everett
Everett, Washington, 98201
United States
Harborview Medical Center
Seattle, Washington, 98104
United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: 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

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 Registration Dates

Study Start Date2020-05-18
Study Completion Date2025-09-05

Study Record Updates

Study Start Date2020-05-18
Study Completion Date2025-09-05

Terms related to this study

Keywords Provided by Researchers

  • Bayesian Adaptive Clinical Trial
  • Hypothermia, therapeutic
  • Coma

Additional Relevant MeSH Terms

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