- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02136979
Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass
CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and CD73 after CPB was not evaluated in previous studies.
The authors hypothesized that the expression of CD39 and CD73 would differ between propofol- and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after CPB.
연구 개요
상세 설명
After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective cardiac surgery under cardiopulmonary bypass (CPB) after signed written informed consent agreements and prospectively participate in the present study.
All patients got a cardiac surgery under moderate hypothermic cardiopulmonary bypass (CPB) by one cardiac surgeon. Also, 6ml of blood and sample was obtained for total 5 times in consecutive order.
- Before operation (pre-CPB1)
- 15 minute after successful CPB weaning (post-CPB1)
- 3 hrs after CPB weaning (post-CPB2)
- 24 hrs after CPB weaning (post-CPB3)
- 48 hrs after CPB weaning (post-CPB4)
The following intraoperative exclusion criteria are applied:
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
Using blood sample, authors examined as follows
- Flow cytometry for Th 17 and Th 1 cell.
- Immunocytochemistry for CD39, CD73.
- Assay for IL 1,6,10,17,IFN-γ, and TNF-α
- patient vital sign during operation
- other laboratory tests
Statistical analyses are conducted using SPSS 20.0 (SPSS Inc., Chicago, IL, USA). CD39 and CD73 are analysed used a Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the tukey method. The comparisons of the other continuous variables are performed by paired t or Wilcoxon Signed Rank tests. Data are expressed as mean ± SD (95% confidence interval. CI) or median (25%-75%), and number of the patients. A p value less than 0.05 is considered statistically significant.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Seoul, 대한민국, 143-729
- Konkuk University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients scheduled to undergo elective cardiac surgery
- signed written informed consent agreements
Exclusion Criteria:
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Propofol group
patients with propofol-based anesthesia
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group of patients with propofol-based anesthesia
다른 이름들:
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활성 비교기: Sevoflurane group
patients with sevoflurane-based anesthesia
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group of patients with sevoflurane-based anesthesia
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The level of CD39 and CD73 between propofol and sevoflurane group after CPB
기간: from preoperative status up to 48 hrs after CPB weaning status
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The difference of CD39 and CD73 level between propofol and sevoflurane group
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from preoperative status up to 48 hrs after CPB weaning status
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공동 작업자 및 조사자
수사관
- 수석 연구원: Seong-Hyop Kim, M.D, Ph.D, Konkuk University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
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