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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation [Срок оценки: 12 months after out-of-hospital cardiac arrest]

Вторичные конечные точки (3)

• Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline [Срок оценки: Baseline and 12 months after cardiac arrest]
• Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months [Срок оценки: 12 months after cardiac arrest]
• Survival at 12 months [Срок оценки: 12 months after cardiac arrest]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 50 центров

• 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
• … и ещё 42 центра

Австралия · 7 центров

• 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

Великобритания · 3 центра

• Bristol Royal Hospital for Children — Bristol
• Evelina London Children's Hospital — London
• Birmingham Children's Hospital, United Kingdom — Birmingham

Канада · 1 центр

• The Hospital for Sick Children — Toronto

Новая Зеландия · 1 центр

• Starship Children's Hospital — Grafton

Идентификаторы

NCT: NCT05376267 · IDE G210126 · 1UG3HL159134-01 · U24HL159132 · HUM00206424

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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