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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients over the age of 20 scheduled for valvular heart surgery

Exclusion criteria

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

Treatment and study plan

atrovastatin

Drug

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

Drug

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.

Primary outcomes

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

BUN/Cr cystatin C eGFR urine output incidence of acute kidney injury(based on the AKIN criteria)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 26, 2013
Registry last updated: Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed