Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery

Peking Union Medical College

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Drug: Atorvastatin(Lipitor); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01547455

2011-1002-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin(Lipitor)

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo