The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study

Yonsei University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Drug: atrovastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01909739

4-2013-0334

Details and patient eligibility

About

The aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(AKI) in patients undergoing valvular heart surgery.

Enrollment: 200 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over the age of 20 scheduled for valvular heart surgery

Exclusion criteria

1. Current statin use
2. Left ventricular ejection fraction < 30%
3. Preexisting congestive heart failure
4. Severe coronary artery disease
5. Hemodynamically unstable arrhythmia
6. Cardiogenic shock during perioperative period
7. Ventricular assist device
8. Severe renal dysfunction (eGFR < 15 ml/min per 1.73 m2)
9. History of liver disease or elevated serum transaminases
10. History of rhabdomyolysis or elevated creatinine kinase

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Statin group

Experimental group

Treatment:

Drug: atrovastatin

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo