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

Child Clinical Trial

— Coolheart  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02395276
• Other study ID #: SMC-0616-13
• Status: Not yet recruiting
• Phase: N/A
• First received: March 17, 2015
• Last updated: March 21, 2015
• Start date: April 2015
• Est. completion date: April 2020

Study information

• Verified date: March 2015
• Source: Sheba Medical Center
• Contact: Omer Bar Yosef, MD-PhD
• Phone: 972-52-6667344
• Email: omer.baryosef[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: April 2020
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Ischemia
• Child
• Congenital Heart Defects
• Heart Defects, Congenital
• Hypothermia
• Hypothermia, Induced
• Hypoxia Brain

Intervention

Device:
• Whole body hypothermia
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours after the surgery	No
Primary	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	10 days after	No
Primary	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	1 week	No
Secondary	Short term neuro-developmental outcome	Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category	2 months	No
Secondary	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	5 yrs	No