Status:
COMPLETED
Cardiopulmonary-bypass and Reno-protective Effect of Atorvastatin Trial
Lead Sponsor:
Austin Health
Conditions:
Acute Kidney Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Acute kidney dysfunction is common after cardiac surgery. While many patients suffer no long-term ill effects from post-operative kidney dysfunction, some require initiation of dialysis therapy that c...
Eligibility Criteria
Inclusion
- Cardiac surgical patients in whom the use of cardiopulmonary bypass was planned
- Written informed consent of patient
- Age \> 18 years
- And having at least one ore more of the following risk factors for postoperative AKI:
- Age =/\> 70 years
- Preoperative plasma creatinine \>120 µmol/L, New York Heart Association class III/IV or LVEF \<35%
- Insulin dependent diabetes mellitus
- Valve surgery (with or without coronary artery bypass graft)
- Redo cardiac surgery
Exclusion
- An emergency operation is indicated (within 24 hours after hospital admission or on intra-aortic balloon pump)
- Pregnancy is confirmed or breastfeeding is present
- A renal allograft is present
- Preoperative acute renal failure within 6 weeks (acute rise in serum creatinine \> 50% from baseline) is present
- Pre-operative end stage renal disease (serum creatinine \> 300 µmol/L) is present
- Chronic moderate to high dose corticosteroid therapy (\>10 mg/d prednisone or equivalent) is present
- Known Allergy to Atorvastatin
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00910221
Start Date
March 1 2008
End Date
September 1 2011
Last Update
September 11 2012
Active Locations (1)
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1
Austin Health
Melbourne, Victoria, Australia, 3084