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Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury (Coolheart)

Primary Purpose

Congenital Heart Defects, Brain Ischemia, Hypoxia Brain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole body hypothermia
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects focused on measuring Congenital Heart Defects, Hypoxic Ischemic Brain Injury, Hypothermia Therapy, Pediatrics

Eligibility Criteria

1 Day - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Every child entering the PCICU, age < 7 years
  2. The child will enter arm 1 or 2 if he underwent the event described in section 3.

  3. Hypoxic ischemic event that would render hypothermia treatment is defined as

    • During the hospitalization in the PCICU before or after the surgery:

    Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation show a serum lactate level of more than 90 mg/dl OR Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation shows a serum lactate level of more than 40 mg/dl and a blood pH level of less than 7.1

    • During the surgery Near infra red spectroscopy lower than 40 for more than 5 minutes AND Serum lactate levels of more than 90 mg/dl during the event OR The patient is re-connected to cardio-pulmonary bypass machine as a result of the event
  4. Initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3.

Exclusion criteria

  • Suspected hypoxic ischemic event as described in the Inclusion Criteria in the 2 weeks prior to the PCICU admission
  • Prolonged low cerebral perfusion before the PCICU admission, with 3 repeated tests in 1 hour of lactate level higher than 40 mg/dl and pH lower than 7.1
  • Rejection criteria
  • A second resuscitation after the hypoxic ischemic event and before a brain MRI is done

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    No Intervention

    Arm Label

    Whole body hypothermia

    Whole body normothermia

    Control

    Arm Description

    Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for whole body hypothermia therapy. Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored. Whole body hypothermia will be to 33 +/- 1 °C . Treatment period will be 48 hours with 24 hours warming up period.

    Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for normothermia therapy. Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored. Cooling will be to 36-37 °C . Treatment period will be 72 hrs.

    A group of children that underwent a cardiac surgery and was not suspected to have an hypoxic ischemic brain injury. This group will be undergo the similar biomarkers collection as arm 1 and 2. The information will be used to measure the change in biomarkers between surgeries with no HII to those in arm 1+2.

    Outcomes

    Primary Outcome Measures

    Biomarkers
    Each child will have 4 blood samples for biomarkers including S100B, Glial Fibrillary Acidic Protein and Specific Neuronal Enolase at the following schedule: before the cardiac surgery, within 6 hr after the surgery, 24 and 48 hrs after the surgery
    Magnetic Resonance Imaging
    In arms 1 and 2 an MRI with the sequences of T1, T2, Diffusion Weighted Imaging, Diffuse Tensor Imaging and Magnetic Resonance Spectroscopy
    Neurological Evaluation
    Neurological assessment will be done prior to the cardiac surgery and and one week (or earlier if the child will be fully recovered and discharged before) using standard neurological evaluation, pediatric stroke outcome measure

    Secondary Outcome Measures

    Short term neuro-developmental outcome
    Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category
    Short term neuro-developmental outcome
    At 2 and 5 yrs after the hypothermia treatment a c. Vineland adaptive behavior scale (Vineland™-II) will be done

    Full Information

    First Posted
    March 17, 2015
    Last Updated
    March 21, 2015
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02395276
    Brief Title
    Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury
    Acronym
    Coolheart
    Official Title
    Efficacy of Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit in Children Suspected for Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    April 2017 (Anticipated)
    Study Completion Date
    April 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII) as result of hemodynamic instability in the perioperative period. Similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely an effective treatment for HII in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound. In this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in PCICUs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Defects, Brain Ischemia, Hypoxia Brain, Child, Hypothermia, Induced
    Keywords
    Congenital Heart Defects, Hypoxic Ischemic Brain Injury, Hypothermia Therapy, Pediatrics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Whole body hypothermia
    Arm Type
    Active Comparator
    Arm Description
    Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for whole body hypothermia therapy. Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored. Whole body hypothermia will be to 33 +/- 1 °C . Treatment period will be 48 hours with 24 hours warming up period.
    Arm Title
    Whole body normothermia
    Arm Type
    Placebo Comparator
    Arm Description
    Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for normothermia therapy. Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored. Cooling will be to 36-37 °C . Treatment period will be 72 hrs.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    A group of children that underwent a cardiac surgery and was not suspected to have an hypoxic ischemic brain injury. This group will be undergo the similar biomarkers collection as arm 1 and 2. The information will be used to measure the change in biomarkers between surgeries with no HII to those in arm 1+2.
    Intervention Type
    Device
    Intervention Name(s)
    Whole body hypothermia
    Other Intervention Name(s)
    ThermoWrap® cover and Alon® Control Unit
    Intervention Description
    Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored. Cooling will be to 33 +/- 1 °C . Treatment period will be 48 hours with 24 hours warming up period.
    Primary Outcome Measure Information:
    Title
    Biomarkers
    Description
    Each child will have 4 blood samples for biomarkers including S100B, Glial Fibrillary Acidic Protein and Specific Neuronal Enolase at the following schedule: before the cardiac surgery, within 6 hr after the surgery, 24 and 48 hrs after the surgery
    Time Frame
    48 hours after the surgery
    Title
    Magnetic Resonance Imaging
    Description
    In arms 1 and 2 an MRI with the sequences of T1, T2, Diffusion Weighted Imaging, Diffuse Tensor Imaging and Magnetic Resonance Spectroscopy
    Time Frame
    10 days after
    Title
    Neurological Evaluation
    Description
    Neurological assessment will be done prior to the cardiac surgery and and one week (or earlier if the child will be fully recovered and discharged before) using standard neurological evaluation, pediatric stroke outcome measure
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Short term neuro-developmental outcome
    Description
    Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category
    Time Frame
    2 months
    Title
    Short term neuro-developmental outcome
    Description
    At 2 and 5 yrs after the hypothermia treatment a c. Vineland adaptive behavior scale (Vineland™-II) will be done
    Time Frame
    5 yrs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Every child entering the PCICU, age < 7 years The child will enter arm 1 or 2 if he underwent the event described in section 3. Hypoxic ischemic event that would render hypothermia treatment is defined as During the hospitalization in the PCICU before or after the surgery: Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation show a serum lactate level of more than 90 mg/dl OR Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation shows a serum lactate level of more than 40 mg/dl and a blood pH level of less than 7.1 During the surgery Near infra red spectroscopy lower than 40 for more than 5 minutes AND Serum lactate levels of more than 90 mg/dl during the event OR The patient is re-connected to cardio-pulmonary bypass machine as a result of the event Initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3. Exclusion criteria Suspected hypoxic ischemic event as described in the Inclusion Criteria in the 2 weeks prior to the PCICU admission Prolonged low cerebral perfusion before the PCICU admission, with 3 repeated tests in 1 hour of lactate level higher than 40 mg/dl and pH lower than 7.1 Rejection criteria A second resuscitation after the hypoxic ischemic event and before a brain MRI is done
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Omer Bar Yosef, MD-PhD
    Phone
    972-52-6667344
    Email
    omer.baryosef@sheba.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amir Vardi, MD
    Phone
    927-3-5308010
    Email
    amir.vardi@sheba.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Omer B Bar Yosef, MD-PhD
    Organizational Affiliation
    Chain Sheba Medical Ceneter
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury

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