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Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery

Information source: Peking Union Medical College
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Kidney Injury

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

Phase: N/A

Status: Completed

Sponsored by: Peking Union Medical College

Official(s) and/or principal investigator(s):
Weipeng Wang, MD,PhD, Principal Investigator, Affiliation: Cardiovascular Institute & Fuwai Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: acute kidney injury

Secondary outcome:

Change of inflammatory biomarkers

Requirement of renal replacement therapy

liver function

death

MACCE events

length of stay in intensive care unit

length of stay in hospital after 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Cardiovascular Institute&Fuwai Hospital, Beijing, Beijing 100037, China
Additional Information

Starting date: April 2012
Last updated: July 24, 2013

Page last updated: August 23, 2015

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