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BACKGROUND: Recent prospective studies have demonstrated that intravenous hydration with sodium bicarbonate (SB) is effective in the prevention of contrast-induced nephropathy (CIN). However, it has not yet been invetigated whether a single bolus intravenous administration of SB immediately before exposure to contrast media can prevent CIN. Accordingly, this prospective, controlled, randomized trial was designed to examine the efficacy of a single bolus administration of SB in the prevention of CIN in patients with renal insufficiency undergoing diagnostic coronary arteriography (CAG) or elective percutaneous coronary intervention (PCI). METHODS: A total of 144 patients with a serum creatinine level of >1.1 mg/dl and <2.0 mg/dl scheduled for diagnostic CAG or elective PCI were enrolled in this study. The patients were randomly assigned to the following 2 groups: standard intravenous hydration with sodium chloride plus a single bolus intravenous administration of SB (20 ml = 20 mEq) 5 min before exposure of contrast media (group A, n = 72) and standard intravenous hydration with sodium chloride alone (group B, n = 72). The primary end point was the development of CIN, defined as an increase of ≥25% or ≥0.5mg in serum creatinine level within 3 days after the procedure. We also evaluated the incidence of adverse clinical events, including acute pulmonary edema, acute renal failure requiring dialysis, and death within the first 7 days after the procedure. RESULTS: There were no significant group differences in age, gender, the frequencies of diabetes mellitus and PCI, serum creatinine at baseline, the volume of contrast media, and drugs administered. The single bolus intravenous administration of SB led to a significant increase in arterial blood pH (7.41 ± 0.04 to 7.43 ± 0.03, p <0.001). The incidence of primary end point was significantly lower in group A than in group B (1.4% vs 12.5%, p = 0.017). The incidence of adverse clinical events did not differ significantly between the 2 groups (0% vs 1.4%). CONCLUSIONS: A single bolus intravenous administration of SB before contrast injection is effective in the prevention of CIN in patients with renal insufficiency undergoing diagnostic CAG or elective PCI.