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

N/ACompletedNCT01909739

Yonsei University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

200

Conditions

Acute Kidney Injury

Interventions

atrovastatinDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

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)

Time frame: renal function change from 24-hour after surgery to 120-hour after surery

Data from ClinicalTrials.gov

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