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

Hypoxia-Ischemia, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05376267
• Other study ID #: IDE G210126
• Secondary ID: 1UG3HL159134-01U
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: March 31, 2028

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Frank Moler, MD
• Phone: 734-764-5302
• Email: fmoler[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Days to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Ischemia
• Cardiac Arrest, Out-Of-Hospital
• Heart Arrest
• Hypothermia
• Hypothermia, Induced
• Hypoxia
• Hypoxia-Ischemia, Brain
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United Kingdom	Birmingham Children's Hospital, United Kingdom	Birmingham
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	University of Michigan CS Mott Children's Hospital	Ann Arbor	Michigan
United States	Johns Hopkins Medicine Children's Center	Baltimore	Maryland
United States	University of Maryland Children's Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham / Children's of Alabama	Birmingham	Alabama
United States	MassGeneral Hospital for Children	Boston	Massachusetts
United States	University of Buffalo / Oishei Children's Hospital	Buffalo	New York
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Ann & Robert Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Comer Children's Hospital, University of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Ohio State University / Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Dayton Children's Hospital	Dayton	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	University of Florida (UF) Health Shands Children's Hospital	Gainesville	Florida
United States	Penn State University / Penn State Children's Hospital	Hershey	Pennsylvania
United States	Texas Children's Hospital, Baylor	Houston	Texas
United States	Riley Children's Health	Indianapolis	Indiana
United States	University of Iowa, Carver College of Medicine	Iowa City	Iowa
United States	Memorial Health - Miller Children's and Women's Hospital of Long Beach	Long Beach	California
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of California Los Angeles (UCLA) Mattel Children's Hospital	Los Angeles	California
United States	American Family Children's Hospital	Madison	Wisconsin
United States	University of Tennesses Health Center / Le Bonheur Children's	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Children's Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Fairview Masonic Children's Hospital	Minneapolis	Minnesota
United States	Cohen Children's Medical Center of NY / Northwell Health	New Hyde Park	New York
United States	Mount Sinai Icahn / Kravis Children's Hospital	New York	New York
United States	University of California - Oakland / UCSF Benoiff Children's Hospital Oakland	Oakland	California
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospital of Illinois	Peoria	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh (UPMC)	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University Doernbecher Children's Hospital	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California, Davis	Sacramento	California
United States	Washington University / St. Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's Hospital, University of Utah School of Medicine	Salt Lake City	Utah
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco	San Francisco	California
United States	Stanford	Santa Clara	California
United States	Banner University Medical Center - Tucson	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Kennedy Krieger Institute, Baltimore, MD, National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation	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.	12 months after out-of-hospital cardiac arrest
Secondary	Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline	The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.	Baseline and 12 months after cardiac arrest
Secondary	Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months	The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.	12 months after cardiac arrest
Secondary	Survival at 12 months		12 months after cardiac arrest