Intravenous N-acetylcysteine for preventing contrast-induced nephropathy: a randomised trial.
BACKGROUND
Studies evaluating the role of N-acetylcysteine in patients undergoing coronary angiography have yielded inconsistent data. Less is known about patients with normal renal function at baseline.


METHODS
Prospective, double-blind, placebo-controlled trial to determine the benefits of intravenous N-acetylcysteine as an adjunct to hydration in this kind of population. Patients were randomly assigned to receive either N-acetylcysteine (600 mg twice daily) or placebo, in addition to 0.45% intravenous saline. The primary end point was development of contrast-induced nephropathy, defined as an acute increase in the serum creatinine concentration > or = 0.5 mg/dl and/or > 25% increase above baseline level at 48 h after contrast dosing.


RESULTS
A total of 216 patients were studied: N-acetylcysteine = 107 and placebo = 109. Treatment groups were similar with respect to baseline clinical characteristics. Overall incidence of contrast-induced nephropathy was 10.2%, 10.3% in the N-acetylcysteine group and 10.1% in the placebo group. Furthermore, no significant differences were observed when considering the non-diabetic population, although there was a trend towards a protective effect of N-acetylcysteine in the subgroup of 47 patients with both hypertension and diabetes. There were no significant changes in serum urea nitrogen concentrations. The incidence of in-hospital adverse clinical events was low: no patient with contrast-induced nephropathy required dialysis, the median Coronary Unit stay was 4.5 vs. 4 days, and the mortality rate was 2.8% vs. 4.6% in the N-acetylcysteine and placebo groups, respectively (p=NS).


CONCLUSIONS
The prophylactic administration of intravenous N-acetylcysteine provides no additional benefit to saline hydration in high-risk coronary patients with normal renal function.
Carbonell
Nieves
N
Coronary Care Unit, Hospital Clínic Universitari, València, Spain.
Blasco
Marisa
M
Sanjuán
Rafael
R
Pérez-Sancho
Esther
E
Sanchis
Juan
J
Insa
Luis
L
Bodí
Vicente
V
Núñez
Julio
J
García-Ramón
Rafael
R
Miguel
Alfonso
A
D000111:Acetylcysteine / Q000008:administration & dosage*; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects / Q000379:methods; D003327:Coronary Disease / Q000000981:diagnostic imaging; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007674:Kidney Diseases / Q000139:chemically induced / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020011:Protective Agents / Q000008:administration & dosage*
D003287:Contrast Media; D020011:Protective Agents; D000111:Acetylcysteine