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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000405516

Enrollment

102

Registered

2006-09-15

Start date

2006-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

atorvastatin 40mg orally starting morning of surgery pre-pump and the same dose continued daily orally for 3 days post-operatively

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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).

Outcome results