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

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909739
• Other study ID #: 4-2013-0334
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: August 21, 2015

Study information

• Verified date: December 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 21, 2015
• Est. primary completion date: August 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• atrovastatin
Atrovastatin 80mg was administered orally on the evening before surgery. Before anesthesia induction, atrovastatin 40mg was administered orally. And atrovastatin 40mg were administered orally in the evening of postoperative days 0, 1, and 2.
• Placebo
Placebo 80mg was administered orally on the evening before surgery. Before anesthesia induction, placebo 40mg was administered orally. And placebo 40mg were administered orally in the evening of postoperative days 0, 1, and 2.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgery	BUN/Cr cystatin C eGFR urine output incidence of acute kidney injury(based on the AKIN criteria)	renal function change from 24-hour after surgery to 120-hour after surery