An interventional study of Atorvastatin(Lipitor) and Placebo in Acute Kidney Injury, sponsored by Peking Union Medical College. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-25.
Sponsored by Peking Union Medical College · Not applicable, Interventional, and Prevention
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.
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.
1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
This study's enrollment of 96 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
Drug: Atorvastatin(Lipitor)
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
Drug: Placebo
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
Also known as: Lipitor
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
acute kidney injury
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.
Time frame: 72 hours after surgery
Change of inflammatory biomarkers
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
Time frame: 48h after surgery
Requirement of renal replacement therapy
proportion need renal replacement therapy in hospital
Time frame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
liver function
liver dysfunction defined as transaminase\>3UNL normal level
Time frame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
death
Time frame: 30 days after discharge from hospital
MACCE events
Time frame: 30 days after discharge from hospital
length of stay in intensive care unit
An average of 2 days
Time frame: From admission to discharge from ICU
length of stay in hospital after surgery
Time frame: From surgery to discharge from hospital, an expected average of 7 days
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College