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Trial record 1 of 1 for:    05376267
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Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05376267
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : May 6, 2023
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Kennedy Krieger Institute, Baltimore, MD
Information provided by (Responsible Party):
Frank W. Moler, M.D, M.S, University of Michigan

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest, Out-Of-Hospital Hypothermia, Induced Hypoxia-Ischemia, Brain Device: Therapeutic Hypothermia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Bayesian Adaptive Design
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessors will be blinded to the treatment assignment of the participant.
Primary Purpose: Treatment
Official Title: Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Actual Study Start Date : August 5, 2022
Estimated Primary Completion Date : March 31, 2028
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Survival at 12 months [ Time Frame: 12 months after cardiac arrest ]

Eligibility Criteria
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Ages Eligible for Study:   2 Days to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05376267


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

Locations
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Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Kennedy Krieger Institute, Baltimore, MD
Investigators
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Principal Investigator: Frank Moler, MD University of Michigan
Principal Investigator: Alex Topjian, MD Children's Hospital of Philadelphia
Principal Investigator: William Meurer, MD University of Michigan
More Information
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Responsible Party: Frank W. Moler, M.D, M.S, Professor of Pediatrics, University of Michigan
ClinicalTrials.gov Identifier: NCT05376267    
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 )
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be stored in the NHLBI data repository after trial completion.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 1 year after publication on main outcome results paper
Access Criteria: Data use agreement with the appropriate NHLBI repository

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Frank W. Moler, M.D, M.S, University of Michigan:
Bayesian Adaptive Clinical Trial
Hypothermia, therapeutic
Coma
Pediatric
Additional relevant MeSH terms:
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Brain Ischemia
Hypoxia-Ischemia, Brain
Heart Arrest
Out-of-Hospital Cardiac Arrest
Ischemia
Hypoxia
Hypothermia
Pathologic Processes
Heart Diseases
 Cardiovascular Diseases
Signs and Symptoms, Respiratory
Body Temperature Changes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Hypoxia, Brain