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

ConditionsCardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, Brain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Hypothermia

    Device

    Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.

Treatment groups

900 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Cooling 0 hoursExperimental treatment 1 intervention
Group B: Cooling 12 hoursExperimental treatment 1 intervention
Group C: Cooling 18 hoursExperimental treatment 1 intervention
Group D: Cooling 24 hoursExperimental treatment 1 intervention
Group E: Cooling 36 hoursExperimental treatment 1 intervention
Group F: Cooling 48 hoursExperimental treatment 1 intervention
Group G: Cooling 60 hoursExperimental treatment 1 intervention
Group H: Cooling 72 hoursExperimental treatment 1 intervention
Group I: Cooling 84 hoursExperimental treatment 1 intervention
Group J: Cooling 96 hoursExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation

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.

Time frame
12 months after out-of-hospital cardiac arrest

Secondary outcomes

1

Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline

The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.

Time frame
Baseline and 12 months after cardiac arrest
2

Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months

The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.

Time frame
12 months after cardiac arrest
3

Survival at 12 months

Time frame
12 months after cardiac arrest

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Kennedy Krieger Institute, Baltimore, MD

Collaborator

Source ClinicalTrials.gov
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