RECRUITING

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

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Conditions

Cardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, BrainBayesian Adaptive Clinical TrialHypothermia, therapeuticComaPediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-05
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05376267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Days to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks
  2. * Chest compressions for at least 2 minutes
  3. * Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
  4. * Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
  5. * Definitive temperature control device initiated
  6. * Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
  7. * Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours
  1. * Glasgow Coma Motor Score (GCMS) = 6
  2. * LAR does not speak English or Spanish
  3. * Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes
  4. * 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)
  5. * Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
  6. * Pre-existing terminal illness, unlikely to survive to one year
  7. * Cardiac arrest associated with brain, thoracic, or abdominal trauma
  8. * Active and refractory severe bleeding prior to randomization
  9. * Extensive burns or skin lesions incompatible with surface cooling
  10. * Planned early withdrawal of life support before 120 hours
  11. * Sickle cell anemia
  12. * Pre-existing cryoglobulinemia
  13. * Non-fatal drowning in ice covered water
  14. * Central nervous system tumor with ongoing chemotherapy
  15. * Previous enrollment in P-ICECAP trial
  16. * Prisoner
  17. * Chronic hypothermia
  18. * New post-cardiac arrest diabetes insipidus
  19. * Pregnancy

Contacts and Locations

Study Contact

Frank Moler, MD
CONTACT
734-764-5302
fmoler@umich.edu
Moni Weber
CONTACT
734-232-4803
monij@umich.edu

Principal Investigator

Frank Moler, MD
PRINCIPAL_INVESTIGATOR
University of Michigan
Alex Topjian, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
William Meurer, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

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
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
Saint Louis, Missouri, 63110
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
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
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

Collaborators and Investigators

Sponsor: University of Michigan

  • Frank Moler, MD, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Alex Topjian, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
  • William Meurer, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-05
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2022-08-05
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • Bayesian Adaptive Clinical Trial
  • Hypothermia, therapeutic
  • Coma
  • Pediatric

Additional Relevant MeSH Terms

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