Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 days
Maximum Age: 17
Healthy Volunteers: f
View:
• Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks
• Chest compressions for at least 2 minutes
• Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
• Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
• Definitive temperature control device initiated
• Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
• Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours
Locations
United States
Alabama
University of Alabama at Birmingham / Children's of Alabama
RECRUITING
Birmingham
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
Banner University Medical Center - Tucson
RECRUITING
Tucson
California
Memorial Health - Miller Children's and Women's Hospital of Long Beach
RECRUITING
Long Beach
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
University of California Los Angeles (UCLA) Mattel Children's Hospital
RECRUITING
Los Angeles
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
RECRUITING
Oakland
Children's Hospital of Orange County
RECRUITING
Orange
University of California, Davis
RECRUITING
Sacramento
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
RECRUITING
San Francisco
Stanford
RECRUITING
Santa Clara
Florida
University of Florida (UF) Health Shands Children's Hospital
RECRUITING
Gainesville
University of Miami
RECRUITING
Miami
Iowa
University of Iowa, Carver College of Medicine
RECRUITING
Iowa City
Illinois
Ann & Robert Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Comer Children's Hospital, University of Chicago
RECRUITING
Chicago
Children's Hospital of Illinois
RECRUITING
Peoria
Indiana
Riley Children's Health
RECRUITING
Indianapolis
Massachusetts
MassGeneral Hospital for Children
RECRUITING
Boston
Maryland
Johns Hopkins Medicine Children's Center
RECRUITING
Baltimore
University of Maryland Children's Hospital
RECRUITING
Baltimore
Michigan
University of Michigan CS Mott Children's Hospital
RECRUITING
Ann Arbor
Children's Hospital of Michigan
RECRUITING
Detroit
Minnesota
University of Minnesota Fairview Masonic Children's Hospital
WITHDRAWN
Minneapolis
Missouri
Washington University / St. Louis Children's Hospital
RECRUITING
St Louis
North Carolina
The University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
University of Buffalo / Oishei Children's Hospital
RECRUITING
Buffalo
Cohen Children's Medical Center of NY / Northwell Health
RECRUITING
New Hyde Park
Mount Sinai Icahn / Kravis Children's Hospital
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
Children's Hospital Medical Center of Akron
RECRUITING
Akron
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Ohio State University / Nationwide Children's Hospital
RECRUITING
Columbus
Dayton Children's Hospital
RECRUITING
Dayton
Oregon
Oregon Health & Science University Doernbecher Children's Hospital
RECRUITING
Portland
Pennsylvania
Penn State University / Penn State Children's Hospital
RECRUITING
Hershey
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh (UPMC)
RECRUITING
Pittsburgh
Tennessee
University of Tennesses Health Center / Le Bonheur Children's
RECRUITING
Memphis
Texas
Children's Medical Center of Dallas
RECRUITING
Dallas
Texas Children's Hospital, Baylor
RECRUITING
Houston
The University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Utah
Primary Children's Hospital, University of Utah School of Medicine
WITHDRAWN
Salt Lake City
Wisconsin
American Family Children's Hospital
RECRUITING
Madison
Children's Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Queensland Children's Hospital
RECRUITING
Brisbane
Monash Medical Centre
RECRUITING
Clayton
Perth Children's Hospital
RECRUITING
Nedlands
Women's and Children's Hospital
RECRUITING
North Adelaide
Royal Children's Hospital
RECRUITING
Parkville
Gold Coast University Hospital
RECRUITING
Southport
Canada
The Hospital for Sick Children
RECRUITING
Toronto
New Zealand
Starship Children's Hospital
RECRUITING
Grafton
United Kingdom
Birmingham Children's Hospital, United Kingdom
RECRUITING
Birmingham
Contact Information
Primary
Frank Moler, MD
fmoler@umich.edu
734-764-5302
Backup
Moni Weber
monij@umich.edu
734-232-4803
Time Frame
Start Date: 2022-08-05
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 900
Treatments
Experimental: Cooling 0 hours
Participants will be kept at a normal temperature for the whole 5 days.
Experimental: Cooling 12 hours
The participant will be cooled to 33°Celsius (C) for 12 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 18 hours
The participant will be cooled to 33°C for 18 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 24 hours
The participant will be cooled to 33°C for 24 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 36 hours
The participant will be cooled to 33°C for 36 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 48 hours
The participant will be cooled to 33°C for 48 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 60 hours
The participant will be cooled to 33°C for 60 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 72 hours
The participant will be cooled to 33°C for 72 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 84 hours
The participant will be cooled to 33°C for 84 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Experimental: Cooling 96 hours
The participant will be cooled to 33°C for 96 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Authors
Barney Scholefield, Marie Steiner, Grace Chan Oei, Jill Sweney, Adnan Bhutta, Allan De Caen, Farhan Bhanji
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: Kennedy Krieger Institute, Baltimore, MD, National Heart, Lung, and Blood Institute (NHLBI)