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Clinical Trials/ACTRN12606000405516
ACTRN12606000405516Not yet recruitingPhase 2

A phase II randomised, double-blind, placebo-controlled study of the effect of atorvastatin on postoperative renal function in patients undergoing elective cardiopulmonary bypass

Austin Hospital, Department of Intensive Care0 sites102 target enrollmentStarted: September 15, 2006Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
102

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Prevention
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to ot stated (—)
Sex
All

Inclusion Criteria

  • 1. Informed consent2. Elective cardiac surgery in males/females3. Planned cardiopulmonary bypass4. >1 risk factors for post-operative renal dysfunction.

Exclusion Criteria

  • 1. 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).

Investigators

Sponsor
Austin Hospital, Department of Intensive Care

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