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

March 28, 2024 updated by: Frank W. Moler, M.D, M.S, University of Michigan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Anne-Marie Guerguerian, MD, PhD
  • United Kingdom
      • Birmingham, United Kingdom
        • Not yet recruiting
        • Birmingham Children's Hospital, United Kingdom
        • Contact:
        • Principal Investigator:
          • Barney Scholefield, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham / Children's of Alabama
        • Contact:
        • Principal Investigator:
          • Michele Kong, MD
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
        • Principal Investigator:
          • F. Anthony Willyerd, MD
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Contact:
          • Mary Gaspers, MD
        • Principal Investigator:
          • Mary Gaspers, MD
    • California
      • Long Beach, California, United States, 90806-1701
        • Recruiting
        • Memorial Health - Miller Children's and Women's Hospital of Long Beach
        • Contact:
        • Principal Investigator:
          • Christopher Babbitt, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles (UCLA) Mattel Children's Hospital
        • Contact:
        • Principal Investigator:
          • Anil Sapru, MD
      • Oakland, California, United States, 94609
        • Recruiting
        • University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
        • Contact:
          • Natalie Cvijanovich, MD
          • Phone Number: 510-428-3302
        • Principal Investigator:
          • Natalie Cvijanovich, MD
      • Orange, California, United States, 92868-4203
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Adam Schwarz, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
        • Principal Investigator:
          • Heather Siefkes, MD
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
        • Contact:
        • Principal Investigator:
          • Patrick McQuillen, MD
      • Santa Clara, California, United States, 95050
        • Recruiting
        • Stanford
        • Contact:
        • Principal Investigator:
          • Tim Cornell, MD
    • Florida
      • Gainesville, Florida, United States, 32610-0296
        • Recruiting
        • University of Florida (UF) Health Shands Children's Hospital
        • Contact:
        • Principal Investigator:
          • Shruthi Mahadevaiah, MD
      • Miami, Florida, United States, 33124
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Jennifer Munoz Pareja, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Craig Smith, MD
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Comer Children's Hospital, University of Chicago
        • Contact:
        • Principal Investigator:
          • Casey Stulce, MD
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • Children's Hospital of Illinois
        • Contact:
        • Principal Investigator:
          • Sandeep Tripathi, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Health
        • Contact:
        • Principal Investigator:
          • Matthew Yuknis, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa, Carver College of Medicine
        • Contact:
        • Principal Investigator:
          • Kari Wellnitz, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Children's Hospital
        • Contact:
        • Principal Investigator:
          • Siddhartha Dante, MD
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medicine Children's Center
        • Contact:
        • Principal Investigator:
          • Caitlin O'Brien, MD, MPH
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • MassGeneral Hospital for Children
        • Contact:
        • Principal Investigator:
          • Sarah Murphy, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan CS Mott Children's Hospital
        • Principal Investigator:
          • Ryan Barbaro, MD
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Children's Hospital of Michigan
        • Contact:
        • Principal Investigator:
          • Kathleen Meert, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Withdrawn
        • University of Minnesota Fairview Masonic Children's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University / St. Louis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Stuart Friess, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University of Buffalo / Oishei Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ryan Breuer, MD
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Cohen Children's Medical Center of NY / Northwell Health
        • Contact:
        • Principal Investigator:
          • Todd Sweberg, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Icahn / Kravis Children's Hospital
        • Contact:
          • Shubhi Kaushik, MD
        • Principal Investigator:
          • Shubhi Kaushik, MD
      • Rochester, New York, United States, 14642-8667
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • Jake Deines, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7220
        • Recruiting
        • The University of North Carolina at Chapel Hill
        • Contact:
          • Benny Joyner, MD, MPH
          • Phone Number: 919-966-7495
          • Email: benny@unc.edu
        • Principal Investigator:
          • Benny Joyner, MD, MPH
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Children's Hospital Medical Center of Akron
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryan Nofziger, MD
        • Principal Investigator:
          • Chris Page-Goertz, MD
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ranjit Chima, MD
      • Columbus, Ohio, United States, 43205
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University Doernbecher Children's Hospital
        • Contact:
          • Mohamud Daya, MD, MS
          • Phone Number: 503-494-7248
          • Email: dayam@ohsu.edu
        • Contact:
        • Principal Investigator:
          • Serena Kelly, MS
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State University / Penn State Children's Hospital
        • Contact:
        • Principal Investigator:
          • Neal Thomas, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Matthew Kirschen, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh (UPMC)
        • Contact:
        • Principal Investigator:
          • Ericka Fink, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • University of Tennesses Health Center / Le Bonheur Children's
        • Contact:
        • Principal Investigator:
          • Alexandra Schaller, DO
    • Texas
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Texas Children's Hospital, Baylor
        • Contact:
        • Principal Investigator:
          • Jennifer Erklauer, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Theodore Wu, MD
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • Primary Children's Hospital, University of Utah School of Medicine
        • Contact:
        • Principal Investigator:
          • Jill Sweney, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • American Family Children's Hospital
        • Contact:
        • Principal Investigator:
          • Peter Ferrazzano, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Wisconsin
        • Contact:
        • Principal Investigator:
          • Binod Balakrishnan, MD

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.

Eligibility Criteria

Ages Eligible for Study

2 days to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cooling 0 hours
Participants will be kept at a normal temperature for the whole 5 days.
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.
Experimental: Cooling 12 hours
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.
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.
Experimental: Cooling 18 hours
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.
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.
Experimental: Cooling 24 hours
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.
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.
Experimental: Cooling 36 hours
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.
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.
Experimental: Cooling 48 hours
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.
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.
Experimental: Cooling 60 hours
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.
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.
Experimental: Cooling 72 hours
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.
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.
Experimental: Cooling 84 hours
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.
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.
Experimental: Cooling 96 hours
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
Time Frame: 12 months after out-of-hospital cardiac arrest
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline
Time Frame: Baseline and 12 months after cardiac arrest
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
Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months
Time Frame: 12 months after cardiac arrest
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
Survival at 12 months
Time Frame: 12 months after cardiac arrest
12 months after cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Kennedy Krieger Institute, Baltimore, MD

Investigators

  • Principal Investigator: Alex Topjian, MD, Children's Hospital of Philadelphia
  • Principal Investigator: William Meurer, MD, University of Michigan
  • Principal Investigator: Frank Moler, MD, 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 Major Dates

Study Start (Actual)

August 5, 2022

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDE G210126
  • 1UG3HL159134-01 (U.S. NIH Grant/Contract)
  • U24HL159132 (U.S. NIH Grant/Contract)
  • HUM00206424 (Other Identifier: UM IRB NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be stored in the NHLBI data repository after trial completion.

IPD Sharing Time Frame

1 year after publication on main outcome results paper

IPD Sharing Access Criteria

Data use agreement with the appropriate NHLBI repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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