RecruitingCardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, Brain

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

Eligible age

0–17 yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

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About this study

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.

Sponsor: University of Michigan

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