N-acetylcysteine does not prevent contrast-induced nephropathy after cardiac catheterization in patients with diabetes mellitus and chronic kidney disease: a randomized clinical trial
Patients with diabetes mellitus (DM) and chronic kidney disease (CKD) constitute to be a high-risk population for the development of contrast-induced nephropathy (CIN), in which the incidence of CIN is estimated to be as high as 50%. We performed this trial to assess the efficacy of N-acetylcysteine (NAC) in the prevention of this complication.
Methods: In a prospective, double-blind, placebo controlled, randomized clinical trial, we studied 90 patients undergoing elective diagnostic coronary angiography with DM and CKD (serum creatinine [greater than or equal to]1.5mg/dL for men and [greater than or equal to]1.4mg/dL for women).
The patients were randomly assigned to receive either oral NAC (600 mg BID, starting 24h before the procedure) or placebo, in adjunct to hydration. Serum creatinine was measured prior to and 48h after coronary angiography.
The primary end-point was the occurrence of CIN, defined as an increase in serum creatinine [greater than or equal to]0.5mg/dL (44.2umol/L) or [greater than or equal to]25% above baseline at 48h after exposure to contrast medium.
Results: Complete data on the outcomes were available on 87 patients, 45 of whom had received NAC. There were no significant differences between the NAC and placebo groups in baseline characteristics, amount of hydration, or type and volume of contrast used, except in gender (male/female, 20/25 and 34/11, respectively; P=0.005) and the use of statins (62.2% and 37.8%, respectively; P=0.034).
CIN occurred in 5 out of 45 (11.1%) patients in the NAC group and 6 out of 42 (14.3%) patients in the placebo group (P=0.656).
Conclusion: There was no detectable benefit for the prophylactic administration of oral NAC over an aggressive hydration protocol in patients with DM and CKD.Trial registration: NCT00808795
Author: Manouchehr AminiMojtaba SalarifarAlireza AmirbaiglooFarzad MasoudkabirFatemeh Esfahani
Credits/Source: Trials 2009, 10:45
Published on: 2009-06-29
Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please
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