Summary

Eligibility
for people ages up to 17 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Patrick McQuillen, MD
Headshot of Patrick McQuillen
Patrick McQuillen

Description

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.

Keywords

Cardiac Arrest, Out-Of-Hospital Hypothermia, Induced Hypoxia-Ischemia, Brain Bayesian Adaptive Clinical Trial Hypothermia, therapeutic Coma Pediatric Brain Ischemia Heart Arrest Out-of-Hospital Cardiac Arrest Ischemia Hypoxia Hypothermia Therapeutic Hypothermia Cooling 0 hours Cooling 12 hours Cooling 18 hours Cooling 24 hours Cooling 36 hours Cooling 48 hours Cooling 60 hours Cooling 72 hours Cooling 84 hours Cooling 96 hours

Eligibility

You can join if…

Open to people ages up to 17 years

  • 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 CAN'T join 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

Locations

  • 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

Lead Scientist at UCSF

  • Patrick McQuillen, MD
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 131 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT05376267
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated