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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01909739

Collaborator

(none)

200

Enrollment

Location

Arms

25.7

Duration (Months)

7.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: atrovastatin Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Aug 21, 2015

Actual Study Completion Date :

Aug 21, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Statin group	Drug: atrovastatin 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 Comparator: Placebo group	Drug: Placebo 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.

Arm

Intervention/Treatment

Experimental: Statin group

Drug: atrovastatin

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 Comparator: Placebo group

Drug: Placebo

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01909739

Other Study ID Numbers:

4-2013-0334

First Posted:

Jul 26, 2013

Last Update Posted:

Mar 28, 2019

Last Verified:

Dec 1, 2015

Keywords provided by Yonsei University

AKI, atrovastatin, Valvular heart surgery

Additional relevant MeSH terms:

Acute Kidney Injury

Study Results

No Results Posted as of Mar 28, 2019