The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2015
CompletedMarch 28, 2019
December 1, 2015
2.1 years
July 24, 2013
March 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Statin group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORInterventions
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 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 Criteria
You may qualify if:
- \- patients over the age of 20 scheduled for valvular heart surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (1)
Park JH, Shim JK, Song JW, Soh S, Kwak YL. Effect of atorvastatin on the incidence of acute kidney injury following valvular heart surgery: a randomized, placebo-controlled trial. Intensive Care Med. 2016 Sep;42(9):1398-407. doi: 10.1007/s00134-016-4358-8. Epub 2016 Apr 27.
PMID: 27120082DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2013
First Posted
July 26, 2013
Study Start
July 1, 2013
Primary Completion
August 21, 2015
Study Completion
August 21, 2015
Last Updated
March 28, 2019
Record last verified: 2015-12