Not Yet RecruitingPhase 2ACTRN12606000405516
Atorvastatin for Renal Protection After Cardiopulmonary Bypass
A phase II randomised, double-blind, placebo-controlled study of the effect of atorvastatin on postoperative renal function in patients undergoing elective cardiopulmonary bypass
Sponsor
Austin Hospital, Department of Intensive Care
Enrollment
102 participants
Start Date
Dec 1, 2006
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria1
- Informed consent2. Elective cardiac surgery in males/females3. Planned cardiopulmonary bypass4. >1 risk factors for post-operative renal dysfunction.
Exclusion Criteria1
- Emergent cardiac surgery, cardiac transplant or insertion of device2. Planned off-pump cardiac surgery3. Hypersensitivity, allergy or known intolerance to statins4. Pre-morbid end-stage kidney disease or renal transplant5. Pre-operative ARF, defined as an increase in serum creatinine ³88.4mmol/L (1.0mg/dL) from pre-admission to operation6. Active liver disease or cirrhosis7. Pre-operative unexplained elevation of serum transaminases8. Enrolled in a conflicting study9. Pregnancy10. Age below 18 years11. Pre-operative acute inflammation (e.g. endocarditis)12. Moderate to high-dose steroid therapy (e.g. >10mg prednisone or equivalent per day).
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Interventions
atorvastatin 40mg orally starting morning of surgery pre-pump and the same dose continued daily orally for 3 days post-operatively
atorvastatin 40mg orally starting morning of surgery pre-pump and the same dose continued daily orally for 3 days post-operatively
Locations(1)
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ACTRN12606000405516