N-acetylcysteine versus AScorbic acid for Preventing contrast-Induced nephropathy in patients with renal insufficiency undergoing coronary angiography: NASPI study—a prospective randomized controlled trial
Received 23 September 2008; accepted 14 November 2008. published online 09 February 2009.
Background
Contrast-induced nephropathy (CIN) is a leading cause of hospital-acquired renal failure and affects mortality and morbidity. There has been no study comparing the efficacy of N-acetylcysteine (NAC) and ascorbic acid that have potential for CIN prevention in patients with renal insufficiency.
Methods
We conducted a prospective randomized controlled trial. A total of 212 patients who had pre-existing renal impairment with basal creatinine clearance ≤60 mL/min and/or serum creatinine (SCr) level of ≥1.1 mg/dL, were randomized to have either high-dose NAC (1,200 mg orally twice a day before and on the day of coronary catheterization, n = 106) or ascorbic acid (3 g and 2 g orally before, and 2 g twice after coronary catheterization with a 12-hour interval, n = 106). The primary end point was the maximum increase of SCr level, and the secondary end point was the incidence of CIN.
Results
The maximum increase of SCr level was significantly lower in NAC group than in ascorbic acid group as follows: −0.03 ± 0.18 mg/dL versus 0.04 ± 0.20 mg/mL, respectively (P = .026). Patients with diabetes or who had received a high dose of contrast media experienced significantly less rise of SCr level with NAC than ascorbic acid; in diabetic subgroup, −0.05 ± 0.22 mg/dL versus 0.09 ± 0.29 mg/mL, respectively (P = .020); in patients with high dose of dye, −0.03 ± 0.17 mg/dL versus 0.04 ± 0.21 mg/mL, respectively (P = .032). The incidence of CIN, the secondary end point, tended to be in favor of NAC rather than ascorbic acid, 1.2% versus 4.4%, respectively (P = .370). Notably, among the diabetes patients, the NAC significantly lowered CIN rate than ascorbic acid, 0% (0/38) versus 12.5% (4/32), respectively (P = .039).
Conclusion
High-dose NAC seems more beneficial than ascorbic acid in preventing contrast-induced renal function deterioration in patients, especially diabetic patients, with renal insufficiency undergoing coronary angiography.
aDivision of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine/Cardiovascular Center, Seoul National University Hospital, Seoul, Korea
bDivision of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Gyeonggi-do, Korea
cCardiovascular Center, Seoul National University Bundang Hospital, Gyeonggi-do, Korea
Reprint requests: Hyo-Soo Kim, MD, PhD or Bon-Kwon Koo, MD, PhD, Department of Internal Medicine, Seoul National University/Cardiovascular Center, Seoul National University Hospital; National Research Laboratory for Cardiovascular Stem Cell, 28 Yongon-dong, Jongno-gu, Seoul 110-744, Korea.
Clinical Trial Identifier: NCT00356954.
This study was supported by a grant from the Innovative Research Institute for Cell Therapy (IRICT: A062260), Republic of Korea, and Clinical Research Center for Ischemic Heart Disease sponsored by the Ministry of Health and Welfare, Republic of Korea (0412-CR02-0704-0001).
1 The affiliation of the first author has changed from Seoul National University Hospital to Hallym University Sacred Heart Hospital since this work was completed.
ABSTRACT