Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Description

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.

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

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.

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

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

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham / Children's of Alabama, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Tucson

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

Long Beach

Memorial Health - Miller Children's and Women's Hospital of Long Beach, Long Beach, California, United States, 90806-1701

Los Angeles

Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027

Los Angeles

University of California Los Angeles (UCLA) Mattel Children's Hospital, Los Angeles, California, United States, 90095

Oakland

University of California - Oakland / UCSF Benoiff Children's Hospital Oakland, Oakland, California, United States, 94609

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868-4203

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

San Francisco

University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco, San Francisco, California, United States, 94158

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

  • * 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
  • * 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
  • * Prisoner
  • * Chronic hypothermia
  • * New post-cardiac arrest diabetes insipidus
  • * Pregnancy

Ages Eligible for Study

2 Days to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Frank Moler, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Alex Topjian, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

William Meurer, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2028-03-31