Recruiting NCT05376267
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapeutic Hypothermia.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain. Basic parameters: 2 Days — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, New Zealand, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Therapeutic Hypothermia
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.
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline [Time frame: Baseline and 12 months after cardiac arrest]
- Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months [Time frame: 12 months after cardiac arrest]
- Survival at 12 months [Time frame: 12 months after cardiac arrest]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 50 centers
- University of Alabama at Birmingham / Children's of Alabama — Birmingham
- Phoenix Children's Hospital — Phoenix
- Banner University Medical Center - Tucson — Tucson
- Memorial Health - Miller Children's and Women's Hospital of Long Beach — Long Beach
- Children's Hospital of Los Angeles — Los Angeles
- University of California Los Angeles (UCLA) Mattel Children's Hospital — Los Angeles
- University of California - Oakland / UCSF Benoiff Children's Hospital Oakland — Oakland
- Children's Hospital of Orange County — Orange
- … and 42 more centers
Australia · 7 centers
- Queensland Children's Hospital — Brisbane
- Townsville University Hospital — Douglas
- Gold Coast University Hospital — Southport
- Women's and Children's Hospital — North Adelaide
- Monash Medical Centre — Clayton
- Royal Children's Hospital — Parkville
- Perth Children's Hospital — Nedlands
United Kingdom · 3 centers
- Bristol Royal Hospital for Children — Bristol
- Evelina London Children's Hospital — London
- Birmingham Children's Hospital, United Kingdom — Birmingham
Canada · 1 center
- The Hospital for Sick Children — Toronto
New Zealand · 1 center
- Starship Children's Hospital — Grafton
Identifiers
NCT: NCT05376267 · IDE G210126 · 1UG3HL159134-01 · U24HL159132 · HUM00206424