Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury (Coolheart)
2015년 3월 21일 업데이트: Dr. Omer Bar-Yosef, Sheba Medical Center
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.
연구 개요
연구 유형
중재적
등록 (예상)
75
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
1일 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
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.
다른 이름들:
|
|
위약 비교기: 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.
|
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.
다른 이름들:
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Biomarkers
기간: 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
|
48 hours after the surgery
|
|
Magnetic Resonance Imaging
기간: 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
|
10 days after
|
|
Neurological Evaluation
기간: 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
|
1 week
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Short term neuro-developmental outcome
기간: 2 months
|
Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category
|
2 months
|
|
Short term neuro-developmental outcome
기간: 5 yrs
|
At 2 and 5 yrs after the hypothermia treatment a c.
Vineland adaptive behavior scale (Vineland™-II) will be done
|
5 yrs
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Omer B Bar Yosef, MD-PhD, Chain Sheba Medical Ceneter
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 4월 1일
기본 완료 (예상)
2017년 4월 1일
연구 완료 (예상)
2020년 4월 1일
연구 등록 날짜
최초 제출
2015년 3월 17일
QC 기준을 충족하는 최초 제출
2015년 3월 20일
처음 게시됨 (추정)
2015년 3월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 3월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 3월 21일
마지막으로 확인됨
2015년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
뇌허혈에 대한 임상 시험
-
University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
Whole body hypothermia에 대한 임상 시험
-
University Hospital, GenevaUniversity of Zurich; Humanitas Hospital, Italy; Kantonsspital Graubünden모병
-
Sunnybrook Health Sciences CentreProstate Cancer Canada알려지지 않은
-
University of Texas Southwestern Medical Center모집하지 않고 적극적으로
-
University of Texas Southwestern Medical Center모집하지 않고 적극적으로
-
Indiana UniversityIndiana University School of Medicine종료됨
-
Assistance Publique - Hôpitaux de ParisHotel Dieu Hospital; Withings; Hôpital Lariboisière Fernand Widal아직 모집하지 않음
-
Assistance Publique - Hôpitaux de ParisWithings아직 모집하지 않음림프종, 비호지킨 | 다발성 골수종