Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain
About this trial
This is an interventional treatment trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma, Pediatric
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
Sites / Locations
- University of Alabama at Birmingham / Children's of AlabamaRecruiting
- Phoenix Children's HospitalRecruiting
- Banner University Medical Center - TucsonRecruiting
- Memorial Health - Miller Children's and Women's Hospital of Long BeachRecruiting
- University of California Los Angeles (UCLA) Mattel Children's HospitalRecruiting
- University of California - Oakland / UCSF Benoiff Children's Hospital OaklandRecruiting
- Children's Hospital of Orange CountyRecruiting
- University of California, DavisRecruiting
- University of California - San Francisco (UCSF) Benioff Children's Hospital San FranciscoRecruiting
- StanfordRecruiting
- University of Florida (UF) Health Shands Children's HospitalRecruiting
- University of MiamiRecruiting
- Ann & Robert Lurie Children's Hospital of ChicagoRecruiting
- Children's Hospital of IllinoisRecruiting
- Riley Children's HealthRecruiting
- University of Iowa, Carver College of MedicineRecruiting
- University of Maryland Children's HospitalRecruiting
- Johns Hopkins Medicine Children's CenterRecruiting
- MassGeneral Hospital for ChildrenRecruiting
- University of Michigan CS Mott Children's HospitalRecruiting
- Children's Hospital of MichiganRecruiting
- University of Minnesota Fairview Masonic Children's Hospital
- Washington University / St. Louis Children's HospitalRecruiting
- University of Buffalo / Oishei Children's HospitalRecruiting
- Cohen Children's Medical Center of NY / Northwell HealthRecruiting
- Mount Sinai Icahn / Kravis Children's HospitalRecruiting
- University of Rochester Medical CenterRecruiting
- The University of North Carolina at Chapel HillRecruiting
- Children's Hospital Medical Center of AkronRecruiting
- Cincinnati Children's HospitalRecruiting
- Ohio State University / Nationwide Children's HospitalRecruiting
- Oregon Health & Science University Doernbecher Children's HospitalRecruiting
- Penn State University / Penn State Children's HospitalRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- Children's Hospital of Pittsburgh (UPMC)Recruiting
- University of Tennesses Health Center / Le Bonheur Children'sRecruiting
- Children's Medical Center of DallasRecruiting
- Texas Children's Hospital, Baylor
- The University of Texas Health Science Center at San AntonioRecruiting
- Primary Children's Hospital, University of Utah School of MedicineRecruiting
- American Family Children's HospitalRecruiting
- Children's WisconsinRecruiting
- The Hospital for Sick Children
- Birmingham Children's Hospital, United Kingdom
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cooling 0 hours
Cooling 12 hours
Cooling 18 hours
Cooling 24 hours
Cooling 36 hours
Cooling 48 hours
Cooling 60 hours
Cooling 72 hours
Cooling 84 hours
Cooling 96 hours
Participants will be kept at a normal temperature for the whole 5 days.
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.
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.
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.
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.
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.
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.
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.
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.
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.