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

NCT ID: NCT01394419

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NAC group

N-acetylcysteine

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

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

Placebo group

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Equal volume of normal saline

Interventions

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N-acetylcysteine

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

Saline

Equal volume of normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 25384603 (View on PubMed)

Other Identifiers

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4-2010-0135

Identifier Type: -

Identifier Source: org_study_id

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