Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 88
- 主要终点
- Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessors will be blinded to the treatment assignment of the participant.
入排标准
- 年龄范围
- 2 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Chronic hypothermia
- •New post-cardiac arrest diabetes insipidus
- •Pregnancy
研究组 & 干预措施
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.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
Cooling 0 hours
Participants will be kept at a normal temperature for the whole 5 days.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
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.
干预措施: Therapeutic Hypothermia (Device)
结局指标
主要结局
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
时间窗: 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.
次要结局
- 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)
研究者
Frank W. Moler, M.D, M.S
Professor of Pediatrics
University of Michigan