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Perioperative N-acetylcysteine to prevent renal dysfunction in high-risk patients undergoing cabg surgery: a
Karen E A Burns1, Michael W A Chu, Richard J Novick
1Division of Critical Care Medicine, University of Western Ontario, London, Ontario, Canada. burnske2@yahoo.ca
Insights
Perioperative N-acetylcysteine did not prevent kidney dysfunction in high-risk patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). Further research is needed to identify at-risk patients and effective interventions.
Area of Science:
- Cardiology
- Nephrology
- Surgical Complications
Background:
- Renal dysfunction is a significant complication following coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB), increasing morbidity and mortality.
- N-acetylcysteine, an antioxidant and vasodilator, has shown potential in counteracting renal ischemia and hypoxia.
Purpose of the Study:
- To evaluate the efficacy of perioperative intravenous N-acetylcysteine in preserving renal function in high-risk patients undergoing CABG surgery with CPB.
- To compare the incidence of postoperative renal dysfunction between N-acetylcysteine and placebo groups.
Main Methods:
- A randomized, quadruple-blind, placebo-controlled trial involving 295 high-risk patients undergoing CABG surgery.
- Patients received four doses of intravenous N-acetylcysteine (600 mg) or placebo over 24 hours.
- Primary outcome: proportion of patients with postoperative renal dysfunction (creatinine increase >0.5 mg/dL or 25% from baseline within 5 days).
Main Results:
- No significant difference in postoperative renal dysfunction between N-acetylcysteine (29.7%) and placebo (29.0%) groups (P = .89).
- Secondary outcomes, including renal replacement therapy, adverse events, and mortality, also showed no significant differences.
- A subgroup analysis of patients with elevated baseline creatinine showed a nonsignificant trend toward benefit with N-acetylcysteine (25.0% vs 37.1%, P = .29).
Conclusions:
- Perioperative N-acetylcysteine did not prevent postoperative renal dysfunction, complications, or mortality in high-risk CABG patients.
- Further research is needed to identify at-risk patients, reliable markers of renal dysfunction, and clinically relevant renal thresholds.
Context:
Renal dysfunction is a complication of coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass (CPB) that is associated with increased morbidity and mortality. N-acetylcysteine, an antioxidant and vasodilator, counteracts renal ischemia and hypoxia.
Objective:
To determine whether perioperative intravenous (IV) N-acetylcysteine preserves renal function in high-risk patients undergoing CABG surgery with CPB compared with placebo.
Design, Setting, And Patients:
Randomized, quadruple blind, placebo-controlled trial (October 2003-September 2004) in operating rooms and general intensive care units (ICUs) of 2 Ontario tertiary care centers. The 295 patients required elective or urgent CABG and had at least 1 of the following: preexisting renal dysfunction, at least 70 years old, diabetes mellitus, impaired left ventricular function, or undergoing concomitant valve or redo surgery.
Interventions:
Patients received 4 (2 intraoperative and 2 postoperative) doses of IV N-acetylcysteine (600 mg) (n = 148) or placebo (n = 147) over 24 hours.
Main Outcome Measures:
The primary outcome was the proportion of patients developing postoperative renal dysfunction, defined by an increase in serum creatinine level greater than 0.5 mg/dL (44 micromol/L) or a 25% increase from baseline within the first 5 postoperative days. Secondary outcomes included postoperative interventions and complications, the requirement for renal replacement therapy (RRT), adverse events, hospital mortality, and ICU and hospital length of stay.
Results:
There was no difference in the proportion of patients with postoperative renal dysfunction (29.7% vs 29.0%, P = .89; relative risk [RR], 1.03 [95% confidence interval {CI}, 0.72-1.46]) in the N-acetylcysteine and placebo groups, respectively. We noted nonsignificant differences in postoperative interventions and complications, the need for RRT (0.7% vs 2.1%; P = .37), total (6.1% vs 9.6%; P = .26) and serious adverse events, hospital mortality (3.4% vs 2.7%; P>.99), and ICU and hospital length of stay between the N-acetylcysteine and placebo groups. A post hoc subgroup analysis of patients (baseline creatinine level >1.4 mg/dL [120 micromol/L]) showed a nonsignificant trend toward fewer patients experiencing postoperative renal dysfunction in the N-acetylcysteine group compared with the placebo group (25.0% vs 37.1%; P = .29).
Conclusions:
N-acetylcysteine did not prevent postoperative renal dysfunction, interventions, complications, or mortality in high-risk patients undergoing CABG surgery with CPB. Further research is required to identify CABG patients at risk for postoperative renal events, valid markers of renal dysfunction, and to establish renal thresholds associated with important clinical outcomes.
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