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Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft

Primary Purpose

Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
N-acetylcysteine
Saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria;

    • preoperative serum creatinine > 1.4 mg/dl
    • Age > 70 years
    • Diabetes mellitus
    • left ventricular ejection fraction < 35 % or congestive heart failure (NYHA III or IV)
    • emergency surgery or re-operation

Exclusion Criteria:

  • preoperative acute renal failure, patients on dialysis, use of N-acetylcystein within 5 days of surgery, history of hypersensitivity to N-acetylcystein

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NAC group

Placebo group

Arm Description

N-acetylcysteine

Saline

Outcomes

Primary Outcome Measures

Incidence of acute kidney injury

Secondary Outcome Measures

Full Information

First Posted
July 13, 2011
Last Updated
March 4, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01394419
Brief Title
Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft
Official Title
Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAC group
Arm Type
Experimental
Arm Description
N-acetylcysteine
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
N-acetylcysteine 150 mg/kg bolus over 15 min after induction of anesthesia, followed by an infusion of 150 mg/kg/day for 24 hrs
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Equal volume of normal saline
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury
Time Frame
within 5 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria; preoperative serum creatinine > 1.4 mg/dl Age > 70 years Diabetes mellitus left ventricular ejection fraction < 35 % or congestive heart failure (NYHA III or IV) emergency surgery or re-operation Exclusion Criteria: preoperative acute renal failure, patients on dialysis, use of N-acetylcystein within 5 days of surgery, history of hypersensitivity to N-acetylcystein
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25384603
Citation
Song JW, Shim JK, Soh S, Jang J, Kwak YL. Double-blinded, randomized controlled trial of N-acetylcysteine for prevention of acute kidney injury in high risk patients undergoing off-pump coronary artery bypass. Nephrology (Carlton). 2015 Feb;20(2):96-102. doi: 10.1111/nep.12361.
Results Reference
derived

Learn more about this trial

Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft

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