Completed

NCT Number: NCT01394419

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

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

Completed

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

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

Saline

Drug

Equal volume of normal saline

Primary outcomes

Incidence of acute kidney injury

Time frame: within 5 days after surgery

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jul 14, 2011
Registry last updated: Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.