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

Launched by UNIVERSITY OF MICHIGAN · May 11, 2022

Keywords

ClinConnect Summary

The P-ICECAP trial is studying how long cooling therapy should be used to help protect the brains of children who have survived cardiac arrest, which is when the heart stops beating outside of a hospital. Researchers believe that cooling the body for a longer time may help more children recover better or improve their recovery if they already show signs of doing well after the incident. This trial is open to children aged 2 days to under 18 years who have been in a coma after being resuscitated from cardiac arrest and require breathing support.

To participate, children must have received chest compressions for at least 2 minutes and have started cooling treatment soon after their heart started beating again. Parents or guardians need to provide consent and agree to keep life support in place for at least 120 hours. If you think your child might qualify, it’s important to discuss this trial with their healthcare team to understand what it involves and how it could potentially help your child’s recovery.

Gender

ALL

Eligibility criteria

• 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