Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100037
- Cardiovascular Institute&Fuwai Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Atorvastatin
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
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participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
其他名称:
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安慰剂比较:Control
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
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Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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acute kidney injury
大体时间:72 hours after surgery
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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.
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72 hours after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of inflammatory biomarkers
大体时间:48h after surgery
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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
大体时间:participants will be followed for the duration of hospital stay , an expected average of 2 weeks
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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
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liver function
大体时间:participants will be followed for the duration of hospital stay , an expected average of 2 weeks
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liver dysfunction defined as transaminase>3UNL normal level
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participants will be followed for the duration of hospital stay , an expected average of 2 weeks
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death
大体时间:30 days after discharge from hospital
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30 days after discharge from hospital
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MACCE events
大体时间:30 days after discharge from hospital
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30 days after discharge from hospital
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length of stay in intensive care unit
大体时间:From admission to discharge from ICU
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An average of 2 days
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From admission to discharge from ICU
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length of stay in hospital after surgery
大体时间:From surgery to discharge from hospital, an expected average of 7 days
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From surgery to discharge from hospital, an expected average of 7 days
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合作者和调查者
调查人员
- 首席研究员:Weipeng Wang, MD,PhD、Chinese Academy of Medical Sciences, Fuwai Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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