Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
4 other identifiers
interventional
900
5 countries
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
June 5, 2026
June 1, 2026
5.7 years
May 11, 2022
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.
12 months after out-of-hospital cardiac arrest
Secondary Outcomes (3)
Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline
Baseline and 12 months after cardiac arrest
Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months
12 months after cardiac arrest
Survival at 12 months
12 months after cardiac arrest
Study Arms (10)
Cooling 0 hours
EXPERIMENTALParticipants will be kept at a normal temperature for the whole 5 days.
Cooling 12 hours
EXPERIMENTALThe 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.
Cooling 18 hours
EXPERIMENTALThe 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.
Cooling 24 hours
EXPERIMENTALThe 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.
Cooling 36 hours
EXPERIMENTALThe 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.
Cooling 48 hours
EXPERIMENTALThe 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.
Cooling 60 hours
EXPERIMENTALThe 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.
Cooling 72 hours
EXPERIMENTALThe 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.
Cooling 84 hours
EXPERIMENTALThe 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.
Cooling 96 hours
EXPERIMENTALThe 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.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- Glasgow Coma Motor Score (GCMS) = 6
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Kennedy Krieger Institute, Baltimore, MDcollaborator
Study Sites (61)
University of Alabama at Birmingham / Children's of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Memorial Health - Miller Children's and Women's Hospital of Long Beach
Long Beach, California, 90806-1701, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California Los Angeles (UCLA) Mattel Children's Hospital
Los Angeles, California, 90095, United States
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
Oakland, California, 94609, United States
Children's Hospital of Orange County
Orange, California, 92868-4203, United States
University of California, Davis
Sacramento, California, 95817, United States
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
San Francisco, California, 94158, United States
Stanford
Santa Clara, California, 95050, United States
University of Florida (UF) Health Shands Children's Hospital
Gainesville, Florida, 32610-0296, United States
University of Miami
Miami, Florida, 33124, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Comer Children's Hospital, University of Chicago
Chicago, Illinois, 60637, United States
Children's Hospital of Illinois
Peoria, Illinois, 61637, United States
Riley Children's Health
Indianapolis, Indiana, 46202, United States
University of Iowa, Carver College of Medicine
Iowa City, Iowa, 52242, United States
University of Maryland Children's Hospital
Baltimore, Maryland, 21201, United States
Johns Hopkins Medicine Children's Center
Baltimore, Maryland, 21287, United States
MassGeneral Hospital for Children
Boston, Massachusetts, 02114, United States
University of Michigan CS Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Minnesota Fairview Masonic Children's Hospital
Minneapolis, Minnesota, 55454, United States
Washington University / St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68114, United States
Albany Medical Center
Albany, New York, 12208, United States
University of Buffalo / Oishei Children's Hospital
Buffalo, New York, 14203, United States
Cohen Children's Medical Center of NY / Northwell Health
New Hyde Park, New York, 11040, United States
Mount Sinai Icahn / Kravis Children's Hospital
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642-8667, United States
Montefiore Einstein Hospital Moses Campus
The Bronx, New York, 10467, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7220, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Ohio State University / Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
Oregon Health & Science University Doernbecher Children's Hospital
Portland, Oregon, 97239, United States
Penn State University / Penn State Children's Hospital
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, 15224, United States
University of Tennesses Health Center / Le Bonheur Children's
Memphis, Tennessee, 38104, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital, Baylor
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Primary Children's Hospital, University of Utah School of Medicine
Salt Lake City, Utah, 84108, United States
American Family Children's Hospital
Madison, Wisconsin, 53705, United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
Queensland Children's Hospital
Brisbane, Queensland, 4101, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Women's and Children's Hospital
North Adelaide, South Australia, 5006, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
The Hospital for Sick Children
Toronto, Ontario, Canada
Starship Children's Hospital
Grafton, Auckland, 1142, New Zealand
Birmingham Children's Hospital, United Kingdom
Birmingham, United Kingdom
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Moler, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Alex Topjian, MD
Children's Hospital of Philadelphia
- PRINCIPAL INVESTIGATOR
William Meurer, MD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessors will be blinded to the treatment assignment of the participant.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 17, 2022
Study Start
August 5, 2022
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
June 5, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 1 year after publication on main outcome results paper
- Access Criteria
- Data use agreement with the appropriate NHLBI repository
The data will be stored in the NHLBI data repository after trial completion.