Clinical trial NCT01547455: Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Official title: Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Statin
kidney function
antiinflammatory effect
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2012-03-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: acute kidney injury
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Change of inflammatory biomarkers
timeFrame: 48h after surgery
measure: Requirement of renal replacement therapy
timeFrame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
measure: liver function
timeFrame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
measure: death
timeFrame: 30 days after discharge from hospital
measure: MACCE events
timeFrame: 30 days after discharge from hospital
measure: length of stay in intensive care unit
timeFrame: From admission to discharge from ICU
measure: length of stay in hospital after surgery
timeFrame: From surgery to discharge from hospital, an expected average of 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute&Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Weipeng Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: