Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Overview
- Phase
- Not Applicable
- Intervention
- Therapeutic Hypothermia
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Sponsor
- University of Michigan
- Enrollment
- 900
- Locations
- 83
- Primary Endpoint
- Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
- Status
- Recruiting
- Last Updated
- 18 days ago
Overview
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 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.
Investigators
Frank W. Moler, M.D, M.S
Professor of Pediatrics
University of Michigan
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
Arms & Interventions
Cooling 24 hours
The participant will be cooled to 33°C for 24 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 96 hours
The participant will be cooled to 33°C for 96 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 0 hours
Participants will be kept at a normal temperature for the whole 5 days.
Intervention: Therapeutic Hypothermia
Cooling 12 hours
The participant will be cooled to 33°Celsius (C) for 12 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 18 hours
The participant will be cooled to 33°C for 18 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 36 hours
The participant will be cooled to 33°C for 36 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 48 hours
The participant will be cooled to 33°C for 48 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 60 hours
The participant will be cooled to 33°C for 60 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 72 hours
The participant will be cooled to 33°C for 72 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Cooling 84 hours
The participant will be cooled to 33°C for 84 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Intervention: Therapeutic Hypothermia
Outcomes
Primary Outcomes
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
Time Frame: 12 months after out-of-hospital cardiac arrest
The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.
Secondary Outcomes
- Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months(12 months after cardiac arrest)
- Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline(Baseline and 12 months after cardiac arrest)
- Survival at 12 months(12 months after cardiac arrest)