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N-acetylcysteine for Prevention of AKI in Off-pump CABG
NCT01394419Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2010
- Primary completion
- Apr 2012
- Countries
- 1
- Sponsor
- Yonsei University
- Modality
- Small Molecules
- Drugs
- acetylcysteine
- Conditions
- acute kidney injury (AKI)
01
Overview
Phase 4, randomised, double-blind trial in acute kidney injury (AKI) comparing NAC group with Placebo group (2 arms). Primary endpoint: Incidence of acute kidney injury at 5 days. Started Sep 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NAC group
N-acetylcysteine 150 mg/kg bolus + 150 mg/kg/day infusion for 24 hrs
Placebo group
Equal volume of normal saline
03
Who it enrols
Patients undergoing off-pump coronary artery bypass surgery who meet 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.
04
Endpoints
Primary
Incidence of acute kidney injury
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