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NCT Number: NCT01547455

Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute&Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin(Lipitor)

Drug

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

Other names: Lipitor

Placebo

Drug

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

Primary outcomes

  1. acute kidney injury

    Time frame: 72 hours after surgery

    Proportion developing AKI using AKIN criteria(stage 1,stage 2, stage3).we plan to measure serum creatinine in baseline, ICU admission,postoperative 6h、Day 1、Day 2 and Day 3.If multiple SCr was measured in one day ,then the highest value will be recorded.Also, we measure creatinine clearance via Cock-croft-Gault formula.

Secondary outcomes

  1. Change of inflammatory biomarkers

    Time frame: 48h after surgery

    we plan to measure IL-6,IL-10,TNF-α and hsCRP at 6 time points: before surgery、after chest closure、postOp.6h、12h、24h and 48h.Compare levels of cytokines between the two arms

  2. Requirement of renal replacement therapy

    Time frame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks

    proportion need renal replacement therapy in hospital

  3. liver function

    Time frame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks

    liver dysfunction defined as transaminase>3UNL normal level

  4. death

    Time frame: 30 days after discharge from hospital

  5. MACCE events

    Time frame: 30 days after discharge from hospital

  6. length of stay in intensive care unit

    Time frame: From admission to discharge from ICU

    An average of 2 days

  7. length of stay in hospital after surgery

    Time frame: From surgery to discharge from hospital, an expected average of 7 days

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2012
Registry last updated
Jul 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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