Prospective randomized study of N‐acetylcysteine, fenoldopam, and saline for prevention of radiocontrast‐induced nephropathy

Abstract

The objective of this study was to compare the efficacy of N-acetylcysteine (NAC), fenoldopam, and saline in preventing radiocontrast-induced nephropathy (RCIN) in high-risk patients undergoing cardiovascular procedures. We prospectively enrolled 123 patients who were scheduled for cardiovascular procedures and had a baseline creatinine > 1.6 mg/dl or creatinine clearance of < 60 ml/min. Patients were randomly assigned to receive either saline (0.45% normal saline at 1 cc/kg) for 12 hr before and 12 hr after the procedure, or fenoldopam (0.1 microg/kg/min) plus saline for 4 hr prior and 4 hr after the procedure, or NAC orally (600 mg) plus saline every 12 hr for 24 hr prior and 24 hr after the procedure. All the patients received low-osmolality nonionic contrast. RCIN was defined as an increase in creatinine level > 0.5 mg/dl after 48 hr. The incidence of RCIN was 17.7% in the NAC group, 15.3% in the saline group, and 15.7% in the fenoldopam group (P = 0.919). Of the 20 patients who developed RCIN, 2 required dialysis. Serum creatinine decreased after 48 hr (vs. baseline) in 38% patients in the NAC group, 18% in the fenoldopam group, and 15% in the saline group. In patients with chronic renal insufficiency, NAC or fenoldopam offered no additional benefit over hydration with saline in preventing RCIN.

Contrast‐induced nephropathy

“…In the first trial, patients were randomized to saline infusion alone (control) or saline with fenoldopam (0.1 lg/kg/min for 4 hr before and after the procedure); a third arm was treated with acetylcysteine. The incidence of CIN was similar in the fenoldopam and control groups (15.7% vs. 15.3%, respectively; P ¼ NS) [78]. The second larger trial by Stone et al [79] confirmed the lack of benefit with fenoldopam.…”

“…In a double-blind, randomized, placebo-controlled pilot trial [77], the combination of fenoldopam and hydration, compared with hydration alone, resulted in an increase in renal plasma flow, a decrease in peak serum creatinine level 72 hr after exposure to contrast media, and a trend toward decreased incidence of CIN (21% and 41%, respectively; P ¼ 0.14). Two other prospective randomized trials showed negative results [78,79]. In the first trial, patients were randomized to saline infusion alone (control) or saline with fenoldopam (0.1 lg/kg/min for 4 hr before and after the procedure); a third arm was treated with acetylcysteine.…”

Contrast induced nephropathy - cardiologist perspective

“…Although several studies showed a protective effect, others demonstrated that oral administration of NAC does not protect renal function; particularly when moderate to high dose of contrast medium are used. 27,47,48,49 Allaqband et al 47 randomized 123 patients to either saline alone or saline plus NAC at a dose of 600 mg orally on the day before and after the day of procedure: no significant difference in CIN was observed between the NAC and the saline-only group. In a trial by Boccaluandro et al 49 , the incidence of CIN in patients with chronic renal insufficiency (creatinine clearance < 50 ml/min) undergoing cardiac catheterization was 13% in the NAC group (600 mg twice daily for 48 h starting the day before the procedure) and 12% in the control group (p = 0.84).…”

Prevenção de nefrotoxicidade por contraste com solução de bicarbonato: resultados preliminares e revisão da literatura

“…The comparison between fenoldopam and placebo regarding the relative risk for CN has favored fenoldopam, but with no statistical significance. [39][40] The lack of effect of the drug may be attributed to insufficient doses to cause renal vasodilation. The use of theophylline or aminophylline has been assessed in nine clinical trials, and the results were conflicting.…”