Study objective: We test the hypothesis that N-acetylcysteine plus normal saline solution is more effective than normal saline solution alone in the prevention of contrast-induced nephropathy. Methods: The design was a randomized, double blind, 2-center, placebo-controlled interventional trial. Inclusion criteria were patients undergoing chest, abdominal, or pelvic computed tomography (CT) scan with intravenous contrast, older than 18 years, and at least one contrast-induced nephropathy risk factor. Exclusion criteria were end-stage renal disease, pregnancy, N-acetylcysteine allergy, or clinical instability. Intervention for the treatment group was N-acetylcysteine 3 g in 500 mL normal saline solution as an intravenous bolus and then 200 mg/hour (67 mL/hour) for up to 24 hours; and for the placebo group was 500 mL normal saline solution and then 67 mL/hour for up to 24 hours. The primary outcome was contrast-induced nephropathy, defined as an increase in creatinine level of 25% or 0.5 mg/dL, measured 48 to 72 hours after CT. Results: The data safety and monitoring board terminated the study early for futility. Of 399 patients enrolled, 357 (89%) completed follow-up and were included. The N-acetylcysteine plus saline solution group contrast-induced nephropathy rate was 14 of 185 (7.6%) versus 12 of 172 (7.0%) in the normal saline solution only group (absolute risk difference 0.6%; 95% confidence interval -4.8% to 6.0%). The contrast-induced nephropathy rate in patients receiving less than 1 L intravenous fluids in the emergency department (ED) was 19 of 147 (12.9%) versus 7 of 210 (3.3%) for greater than 1 L intravenous fluids (difference 9.6%; 95% confidence interval 3.7% to 15.5%), a 69% risk reduction (odds ratio 0.41; 95% confidence interval 0.21 to 0.80) per liter of intravenous fluids. Conclusion: We did not find evidence of a benefit for N-acetylcysteine administration to our ED patients undergoing contrast-enhanced CT. However, we did find a significant association between volume of intravenous fluids administered and reduction in contrast-induced nephropathy.
ASJC Scopus subject areas
- Emergency Medicine