- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01547455
Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
연구 개요
상세 설명
Acute kidney injury occurs up to 30% in cardiac surgery which influenced patients' mid-term and long-term outcomes. Furthermore, evidence shows patients who initiate renal placement therapy in hospital have higher mortality and morbility. The pathologies of Cardiac surgery-associated acute kidney injury (CSA-AKI) is not clear yet ,many researches find cardiopulmonary bypass is an independent risk factor in developing AKI, and inflammatory bursts during cardiopulmonary bypass (CPB) may play an important role in CSA-AKI.
Statins are reported to have anti-inflammatory reaction in many researches. In Some multicenter RCTS, Statins are reported to reduce myocardial infarction,atrial fibrillation and have renoprotective effects due to pleiotropic effects in percutaneous coronary intervention. While in the cardiac surgery settings, the renoprotective effect of statin is still controversial. The investigators believe the differences between surgery and PCI may contribute to the discrepancy. The investigators plan to test the renoprotective effect of atorvastatin in a randomized,double-blind control manner and try to explore the mechanism of this protective effect.
The investigators hypothesise loading dose atorvastatin pretreatment in elective coronary artery bypass grafting surgery may attenuate inflammatory response in CPB and therefore reduce postoperative AKI or help recovery from AKI.
The investigators randomize patients into two arms, the Atorvastatin group takes Atorvastatin 80mg 12h before surgery with another 40mg 2h before operation, the control arm takes placebo in the same regime. The investigators plan to compare the inflammatory cytokines at different time points and the incidence of AKI between the two groups. The investigators hope Atorvastatin group can decrease AKI incidence and has a lower level of inflammatory cytokines, what's more, the two have a good correlation in the time frame.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Beijing
-
Beijing, Beijing, 중국, 100037
- Cardiovascular Institute&Fuwai Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age > 18 years old
- elective coronary artery bypass surgery in CPB
Exclusion Criteria:
- emergent surgery
- re-operation
- acute kidney dysfunction
- chronic kidney disease
- GFR < 60ml/min
- liver dysfunction
- existing myopathy
- LEVF < 40%
- statin allergic or contradictive
- pregnancy
- breast feed period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Atorvastatin
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
|
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
다른 이름들:
|
|
위약 비교기: Control
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
|
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
acute kidney injury
기간: 72 hours after surgery
|
Proportion developing AKI using AKIN criteria(stage 1,stage 2, stage3).we
plan to measure serum creatinine in baseline, ICU admission,postoperative 6h、Day 1、Day 2 and Day 3.If multiple SCr was measured in one day ,then the highest value will be recorded.Also, we measure creatinine clearance via Cock-croft-Gault formula.
|
72 hours after surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change of inflammatory biomarkers
기간: 48h after surgery
|
we plan to measure IL-6,IL-10,TNF-α and hsCRP at 6 time points: before surgery、after chest closure、postOp.6h、12h、24h
and 48h.Compare levels of cytokines between the two arms
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48h after surgery
|
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Requirement of renal replacement therapy
기간: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
proportion need renal replacement therapy in hospital
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participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
|
liver function
기간: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
liver dysfunction defined as transaminase>3UNL normal level
|
participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
|
death
기간: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
|
|
MACCE events
기간: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
|
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length of stay in intensive care unit
기간: From admission to discharge from ICU
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An average of 2 days
|
From admission to discharge from ICU
|
|
length of stay in hospital after surgery
기간: From surgery to discharge from hospital, an expected average of 7 days
|
From surgery to discharge from hospital, an expected average of 7 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Weipeng Wang, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2011-1002-007
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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