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

NCT ID: NCT02395276

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2020-04-30

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.

Conditions

Congenital Heart Defects; Brain Ischemia; Hypoxia Brain; Child; Hypothermia, Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Whole body hypothermia

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.

Group Type: ACTIVE_COMPARATOR

Whole body hypothermia

Intervention Type: DEVICE

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.

Whole body normothermia

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.

Group Type: PLACEBO_COMPARATOR

Whole body hypothermia

Intervention Type: DEVICE

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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ThermoWrap® cover and Alon® Control Unit

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Omer Bar-Yosef

Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omer B Bar Yosef, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Chain Sheba Medical Ceneter

Central Contacts

Omer Bar Yosef, MD-PhD

Role: CONTACT

omer.baryosef@sheba.health.gov.il

972-52-6667344

Amir Vardi, MD

Role: CONTACT

amir.vardi@sheba.health.gov.il

927-3-5308010

Other Identifiers

SMC-0616-13

Identifier Type: -

Identifier Source: org_study_id