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

Recruiting now · Not applicable

Conditions studied: Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain

In brief

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.

Key facts

Study ID

NCT05376267

Run by

University of Michigan

People needed

900

Starts

2022-08-05

Expected to finish

2028-03-31

Last updated by the study team

2026-07-13

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• Washington University / St. Louis Children's Hospital — St Louis, Missouri, United States (enrolling)
• Memorial Health - Miller Children's and Women's Hospital of Long Beach — Long Beach, California, United States (enrolling)
• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• University of Alabama at Birmingham / Children's of Alabama — Birmingham, Alabama, United States (enrolling)
• University of California - Oakland / UCSF Benoiff Children's Hospital Oakland — Oakland, California, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• University of California, Davis — Sacramento, California, United States (enrolling)
• University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco — San Francisco, California, United States (enrolling)
• Stanford — Santa Clara, California, United States (enrolling)
• University of California Los Angeles (UCLA) Mattel Children's Hospital — Los Angeles, California, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Comer Children's Hospital, University of Chicago — Chicago, Illinois, United States (enrolling)
• Children's Hospital of Illinois — Peoria, Illinois, United States (enrolling)
• Riley Children's Health — Indianapolis, Indiana, United States (enrolling)
• University of Iowa, Carver College of Medicine — Iowa City, Iowa, United States (enrolling)
• University of Maryland Children's Hospital — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins Medicine Children's Center — Baltimore, Maryland, United States (enrolling)
• MassGeneral Hospital for Children — Boston, Massachusetts, United States (enrolling)
• University of Michigan CS Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Children's Hospital of Michigan — Detroit, Michigan, United States (enrolling)
• University of Florida (UF) Health Shands Children's Hospital — Gainesville, Florida, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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