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临床试验/NCT01547455
NCT01547455已完成不适用

Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG

Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
acute kidney injury

研究概览

简要总结

Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative stress effects and stabilise plaque in some conditions. Some researches indicate loading dose statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were significantly decreased. The investigators hypothesis loading dose atorvastatin may attenuate inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce postoperative acute kidney injury in cardiac surgery.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years old
  • elective coronary artery bypass surgery in CPB

排除标准

  • 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

研究组 & 干预措施

Atorvastatin

Experimental

participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery

干预措施: Atorvastatin(Lipitor) (Drug)

Control

Placebo Comparator

Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery

干预措施: Placebo (Drug)

结局指标

主要结局

acute kidney injury

时间窗: 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.

次要结局

  • Change of inflammatory biomarkers(48h after surgery)
  • Requirement of renal replacement therapy(participants will be followed for the duration of hospital stay , an expected average of 2 weeks)
  • liver function(participants will be followed for the duration of hospital stay , an expected average of 2 weeks)
  • death(30 days after discharge from hospital)
  • MACCE events(30 days after discharge from hospital)
  • length of stay in intensive care unit(From admission to discharge from ICU)
  • length of stay in hospital after surgery(From surgery to discharge from hospital, an expected average of 7 days)

研究者

发起方
Peking Union Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shan Zhou

Principal Investigator

Peking Union Medical College

研究点 (1)

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