Atorvastatin for Renal Protection After Cardiopulmonary Bypass

Phase 2

• Conditions: Acute kidney injury; Cardiac surgery with cardiopulmonary bypass

• Registration Number: ACTRN12606000405516
• Lead Sponsor: Austin Hospital, Department of Intensive Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 102

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute kidney injury as measured by change in serum creatinine[ 72 hours post-operative.]

Secondary Outcome Measures

Name	Time	Method
Systemic markers of oxidative stress and inflammation, drug toxicity, adverse events, length of stay, need for renal replacement therapy, death.[72 hours post-operative and at any time during the period of hospitalization.]