Congenital Heart DefectsCoolheartNCT02395276
Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury
A study testing Whole body hypothermia in people with Congenital Heart Defects and Brain Ischemia, run by Sheba Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 7 years
- Conditions the study is for
- Congenital Heart Defects, Brain Ischemia, Hypoxia Brain
- What is being tested?
- Whole body hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit in Children Suspected for Brain Injury
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.
- Being tested
- Whole body hypothermia
- Keywords
- Congenital Heart Defects, Hypoxic Ischemic Brain Injury, Hypothermia Therapy, Pediatrics
- Medical subject headings
- Heart Defects, Congenital, Brain Ischemia, Hypoxia, Brain, Hypothermia, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body hypothermiaDevice
Also called ThermoWrap® cover and Alon® Control Unit
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole body hypothermia | Active comparator | 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. Receives: Device: Whole body hypothermia |
| Whole body normothermia | Placebo comparator | 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. Receives: Device: Whole body hypothermia |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours 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
Measured: 10 days after
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
Measured: 1 week
Secondary outcomes (2)
Short term neuro-developmental outcome
Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category
Measured: 2 months
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
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Omer Bar-Yosef, Sheba Medical Center
- Investigators
- Omer B Bar Yosef, MD-PhD, Principal investigator, Chain Sheba Medical Ceneter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395276
- Sponsor's protocol ID
- SMC-0616-13
- Acronym
- Coolheart
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit in Children Suspected for Brain Injury
- ClinicalTrials.gov ID
- NCT02395276
- Acronym / sponsor ID
- Coolheart / SMC-0616-13
- Keywords
- Congenital Heart Defects, Hypoxic Ischemic Brain Injury, Hypothermia Therapy, Pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole body hypothermia | Active comparator | Device: Whole body hypothermiaChildren 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. |
| Whole body normothermia | Placebo comparator | Device: Whole body hypothermiaChildren 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 1 day to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- 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
- Initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body hypothermiaAlso: ThermoWrap® cover and Alon® Control UnitTreatment 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. | Device | Whole body hypothermia, Whole body normothermia |
Primary outcome
Biomarkers
Time frame: 48 hours after the surgery
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
Time frame: 10 days after
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
Time frame: 1 week
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
2 secondary outcomes
Short term neuro-developmental outcome
Time frame: 2 months
Short term neuro-developmental outcome
Time frame: 5 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer B Bar Yosef, MD-PhD principal investigator
Chain Sheba Medical Ceneter
Questions about this trial
What is this clinical trial studying?
A study testing Whole body hypothermia in people with Congenital Heart Defects and Brain Ischemia, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omer Bar Yosef, MD-PhD (972-52-6667344, omer.baryosef@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers (time frame: 48 hours after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.