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NCT05376267NARecruiting

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

University of Michigan

Start Date

8/5/2022

Completion Date

3/31/2028

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

Age Range: No minimum to 17 years

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

Interventions

DEVICE

Therapeutic Hypothermia

Interested in This Trial?

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Conditions

Cardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, Brain

Locations

University of Alabama at Birmingham / Children's of Alabama

Birmingham, Alabama 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Banner University Medical Center - Tucson

Tucson, Arizona 85719

United States

Memorial Health - Miller Children's and Women's Hospital of Long Beach

Long Beach, California 90806-1701

United States

Children's Hospital of Los Angeles

Los Angeles, California 90027

United States

University of California Los Angeles (UCLA) Mattel Children's Hospital

Los Angeles, California 90095

United States

University of California - Oakland / UCSF Benoiff Children's Hospital Oakland

Oakland, California 94609

United States

Children's Hospital of Orange County

Orange, California 92868-4203

United States

University of California, Davis

Sacramento, California 95817

United States

University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco

San Francisco, California 94158

United States

Stanford

Santa Clara, California 95050

United States

University of Florida (UF) Health Shands Children's Hospital

Gainesville, Florida 32610-0296

United States

University of Miami

Miami, Florida 33124

United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida 33701

United States

Ann & Robert Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Comer Children's Hospital, University of Chicago

Chicago, Illinois 60637

United States

Children's Hospital of Illinois

Peoria, Illinois 61637

United States

Riley Children's Health

Indianapolis, Indiana 46202

United States

University of Iowa, Carver College of Medicine

Iowa City, Iowa 52242

United States

University of Maryland Children's Hospital

Baltimore, Maryland 21201

United States

Johns Hopkins Medicine Children's Center

Baltimore, Maryland 21287

United States

MassGeneral Hospital for Children

Boston, Massachusetts 02114

United States

University of Michigan CS Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

Children's Hospital of Michigan

Detroit, Michigan 48201

United States

University of Minnesota Fairview Masonic Children's Hospital

Minneapolis, Minnesota 55454

United States

Washington University / St. Louis Children's Hospital

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68114

United States

Albany Medical Center

Albany, New York 12208

United States

University of Buffalo / Oishei Children's Hospital

Buffalo, New York 14203

United States

Cohen Children's Medical Center of NY / Northwell Health

New Hyde Park, New York 11040

United States

Mount Sinai Icahn / Kravis Children's Hospital

New York, New York 10029

United States

University of Rochester Medical Center

Rochester, New York 14642-8667

United States

Montefiore Einstein Hospital Moses Campus

The Bronx, New York 10467

United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599-7220

United States

Children's Hospital Medical Center of Akron

Akron, Ohio 44308

United States

Cincinnati Children's Hospital

Cincinnati, Ohio 45229

United States

Ohio State University / Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Dayton Children's Hospital

Dayton, Ohio 45404

United States

Oregon Health & Science University Doernbecher Children's Hospital

Portland, Oregon 97239

United States

Penn State University / Penn State Children's Hospital

Hershey, Pennsylvania 17033

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Children's Hospital of Pittsburgh (UPMC)

Pittsburgh, Pennsylvania 15224

United States

University of Tennesses Health Center / Le Bonheur Children's

Memphis, Tennessee 38104

United States

Children's Medical Center of Dallas

Dallas, Texas 75235

United States

Children's Memorial Hermann Hospital

Houston, Texas 77030

United States

Texas Children's Hospital, Baylor

Houston, Texas 77030

United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States

Primary Children's Hospital, University of Utah School of Medicine

Salt Lake City, Utah 84108

United States

American Family Children's Hospital

Madison, Wisconsin 53705

United States

Children's Wisconsin

Milwaukee, Wisconsin 53226

United States

Queensland Children's Hospital

Brisbane, Queensland 4101

Australia

Townsville University Hospital

Douglas, Queensland

Australia

Gold Coast University Hospital

Southport, Queensland

Australia

Women's and Children's Hospital

North Adelaide, South Australia 5006

Australia

Monash Medical Centre

Clayton, Victoria 3168

Australia

Royal Children's Hospital

Parkville, Victoria 3052

Australia

Perth Children's Hospital

Nedlands, Western Australia

Australia

The Hospital for Sick Children

Toronto, Ontario

Canada

Starship Children's Hospital

Grafton, Auckland 1142

New Zealand

Bristol Royal Hospital for Children

Bristol, Bristol BS2 8BJ

United Kingdom

Evelina London Children's Hospital

London, London SE17EH

United Kingdom

Birmingham Children's Hospital, United Kingdom

Birmingham,

United Kingdom