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 biomarkersRequirement 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
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