Clinical trial NCT05376267: Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Official title: Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
Keywords: Bayesian Adaptive Clinical Trial
Hypothermia, therapeutic
Coma
Pediatric
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Kennedy Krieger Institute, Baltimore, MD
First posted: 2022-05-17
Enrollment: 900
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bayesian Adaptive Design
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
timeFrame: 12 months after out-of-hospital cardiac arrest
Secondary outcomes:
measure: Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline
timeFrame: Baseline and 12 months after cardiac arrest
measure: Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months
timeFrame: 12 months after cardiac arrest
measure: Survival at 12 months
timeFrame: 12 months after cardiac arrest
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham / Children's of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Long Beach
country: United States
facility: Memorial Health - Miller Children's and Women's Hospital of Long Beach
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA) Mattel Children's Hospital
state: California
city: Oakland
country: United States
facility: University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
state: California
city: Santa Clara
country: United States
facility: Stanford
state: California
city: Gainesville
country: United States
facility: University of Florida (UF) Health Shands Children's Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Ann & Robert Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Comer Children's Hospital, University of Chicago
state: Illinois
city: Peoria
country: United States
facility: Children's Hospital of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Riley Children's Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa, Carver College of Medicine
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Children's Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medicine Children's Center
state: Maryland
city: Boston
country: United States
facility: MassGeneral Hospital for Children
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan CS Mott Children's Hospital
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Fairview Masonic Children's Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University / St. Louis Children's Hospital
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo / Oishei Children's Hospital
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of NY / Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai Icahn / Kravis Children's Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University / Nationwide Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University Doernbecher Children's Hospital
state: Oregon
city: Hershey
country: United States
facility: Penn State University / Penn State Children's Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh (UPMC)
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennesses Health Center / Le Bonheur Children's
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital, Baylor
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital, University of Utah School of Medicine
state: Utah
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
city: Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Grafton
country: New Zealand
facility: Starship Children's Hospital
state: Auckland
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital, United Kingdom
Study officials:
affiliation: University of Michigan
name: Frank Moler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Alex Topjian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: William Meurer, MD
role: PRINCIPAL_INVESTIGATOR
References: