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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01909739
• Date of registration: 24/07/2013
• Prospective Registration: No
• Primary sponsor: Yonsei University
• Public title: The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study
• Date of first enrolment: July 2013
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01909739
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Kidney Injury

Intervention(s)

Drug: atrovastatin

Drug: Placebo

Primary Outcome(s)

Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgery [Time Frame: renal function change from 24-hour after surgery to 120-hour after surery]

Secondary ID(s)

4-2013-0334

Source(s) of Monetary Support

Please refer to primary and secondary sponsors