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

Primary Purpose

Acute Kidney Injury

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

atrovastatin

Placebo

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring AKI, atrovastatin, Valvular heart surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Statin group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT01909739

First Posted

July 24, 2013

Last Updated

March 27, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01909739

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

August 21, 2015 (Actual)

Study Completion Date

August 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

AKI, atrovastatin, Valvular heart surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Statin group

Arm Type

Experimental

Arm Title

Placebo group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

atrovastatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgery

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

27120082

Citation

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.

Results Reference

derived

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

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