Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
NCT ID: NCT05376267
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2022-08-05
2028-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cooling 0 hours
Participants will be kept at a normal temperature for the whole 5 days.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
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.
Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
Interventions
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Therapeutic Hypothermia
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,
A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* LAR does not speak English or Spanish
* Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes
* Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO)
* Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
* Pre-existing terminal illness, unlikely to survive to one year
* Cardiac arrest associated with brain, thoracic, or abdominal trauma
* Active and refractory severe bleeding prior to randomization
* Extensive burns or skin lesions incompatible with surface cooling
* Planned early withdrawal of life support before 120 hours
* Sickle cell anemia
* Pre-existing cryoglobulinemia
* Non-fatal drowning in ice covered water
* Central nervous system tumor with ongoing chemotherapy
* Previous enrollment in P-ICECAP trial
* Prisoner
* Chronic hypothermia
* New post-cardiac arrest diabetes insipidus
* Pregnancy
2 Days
17 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Kennedy Krieger Institute, Baltimore, MD
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Frank W. Moler, M.D, M.S
Professor of Pediatrics
Principal Investigators
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Frank Moler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Alex Topjian, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
William Meurer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Alabama at Birmingham / Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Memorial Health - Miller Children's and Women's Hospital of Long Beach
Long Beach, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California Los Angeles (UCLA) Mattel Children's Hospital
Los Angeles, California, United States
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California, Davis
Sacramento, California, United States
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
San Francisco, California, United States
Stanford
Santa Clara, California, United States
University of Florida (UF) Health Shands Children's Hospital
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Comer Children's Hospital, University of Chicago
Chicago, Illinois, United States
Children's Hospital of Illinois
Peoria, Illinois, United States
Riley Children's Health
Indianapolis, Indiana, United States
University of Iowa, Carver College of Medicine
Iowa City, Iowa, United States
University of Maryland Children's Hospital
Baltimore, Maryland, United States
Johns Hopkins Medicine Children's Center
Baltimore, Maryland, United States
MassGeneral Hospital for Children
Boston, Massachusetts, United States
University of Michigan CS Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Minnesota Fairview Masonic Children's Hospital
Minneapolis, Minnesota, United States
Washington University / St. Louis Children's Hospital
St Louis, Missouri, United States
University of Buffalo / Oishei Children's Hospital
Buffalo, New York, United States
Cohen Children's Medical Center of NY / Northwell Health
New Hyde Park, New York, United States
Mount Sinai Icahn / Kravis Children's Hospital
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Ohio State University / Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Oregon Health & Science University Doernbecher Children's Hospital
Portland, Oregon, United States
Penn State University / Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, United States
University of Tennesses Health Center / Le Bonheur Children's
Memphis, Tennessee, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Texas Children's Hospital, Baylor
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Primary Children's Hospital, University of Utah School of Medicine
Salt Lake City, Utah, United States
American Family Children's Hospital
Madison, Wisconsin, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
Queensland Children's Hospital
Brisbane, Queensland, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
The Hospital for Sick Children
Toronto, Ontario, Canada
Starship Children's Hospital
Grafton, Auckland, New Zealand
Birmingham Children's Hospital, United Kingdom
Birmingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Mary Gaspers, MD
Role: primary
Natalie Cvijanovich, MD
Role: primary
Shubhi Kaushik, MD
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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