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Status:

RECRUITING

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

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Kennedy Krieger Institute, Baltimore, MD

Conditions:

Cardiac Arrest, Out-Of-Hospital

Hypothermia, Induced

Eligibility:

All Genders

2-17 years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • Inclusion 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
  • Exclusion criteria:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 5 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 31 2028

    Estimated Enrollment :

    900 Patients enrolled

    Trial Details

    Trial ID

    NCT05376267

    Start Date

    August 5 2022

    End Date

    March 31 2028

    Last Update

    December 2 2025

    Active Locations (55)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 14 (55 locations)

    1

    University of Alabama at Birmingham / Children's of Alabama

    Birmingham, Alabama, United States, 35233

    2

    Phoenix Children's Hospital

    Phoenix, Arizona, United States, 85016

    3

    Banner University Medical Center - Tucson

    Tucson, Arizona, United States, 85719

    4

    Memorial Health - Miller Children's and Women's Hospital of Long Beach

    Long Beach, California, United States, 90806-1701