Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery

NCT ID: NCT01547455

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-07-31

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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Atorvastatin

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

Group Type: EXPERIMENTAL

Atorvastatin(Lipitor)

Intervention Type: DRUG

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

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Atorvastatin(Lipitor)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Lipitor

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Shan Zhou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weipeng Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Cardiovascular Institute&Fuwai Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2011-1002-007

Identifier Type: -

Identifier Source: org_study_id