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

University of Michigan

Status: Enrolling

Conditions: Hypothermia, Induced; Cardiac Arrest, Out-Of-Hospital; Hypoxia-Ischemia, Brain

Treatments: Device: Therapeutic Hypothermia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05376267

1UG3HL159134-01 (U.S. NIH Grant/Contract)

U24HL159132 (U.S. NIH Grant/Contract)

IDE G210126

HUM00206424 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 2 days to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 10 patient groups

Cooling 0 hours

Experimental group

Description:

Participants will be kept at a normal temperature for the whole 5 days.

Treatment:

Device: Therapeutic Hypothermia

Cooling 12 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 18 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 24 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 36 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 48 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 60 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 72 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 84 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia

Cooling 96 hours

Experimental group

Description:

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.

Treatment:

Device: Therapeutic Hypothermia