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CLINICAL RESEARCH: INVASIVE CARDIOLOGY

Sodium Bicarbonate Versus Saline for the Prevention of Contrast-Induced Nephropathy in Patients With Renal Dysfunction Undergoing Coronary Angiography or Intervention

Division of Cardiology, Misericordia e Dolce Hospital, Prato, Italy.

Manuscript received March 7, 2008; revised manuscript received May 5, 2008, accepted May 5, 2008.

^_* Reprint requests and correspondence: Dr. Mauro Maioli, Via degli Arcipressi 3, 50143, Florence, Italy. (Email: mauro.maioli{at}fastwebnet.it).

Objectives: The purpose of this study was to compare the efficacy of sodium bicarbonate versus isotonic saline in addition to N-acetylcysteine (NAC) to prevent contrast-induced nephropathy (CIN) in a larger population of patients with renal dysfunction undergoing coronary angiography or intervention.

Background: Contrast-induced nephropathy accounts for more than 10% of hospital-acquired renal failure. Recent studies suggest that hydration with sodium bicarbonate is more protective than isotonic saline in the prevention of CIN.

Methods: The prospective, single center study included 502 patients with estimated creatinine clearance <60 ml/min, randomized to receive infusion of either saline or sodium bicarbonate before and after iso-osmolar contrast medium administration. All patients received oral NAC 600 mg twice a day. Contrast-induced nephropathy was defined as an absolute increase of serum creatinine 0.5 mg/dl measured within 5 days.

Results: Contrast-induced nephropathy occurred in 54 patients (10.8%); 25 (10%) were treated with sodium bicarbonate and 29 (11.5%) with saline (p = 0.60). In patients with CIN, the mean increase in creatinine was not significantly different in the 2 study groups (0.9 ± 0.6 mg/dl vs. 0.7 ± 0.2 mg/dl, respectively; p = 0.15). Only 2 patients needed temporary hemofiltration.

Conclusions: Hydration with sodium bicarbonate plus NAC before contrast medium exposure is not more effective than hydration with isotonic saline plus NAC for prophylaxis of CIN in patients with moderate-to-severe renal dysfunction. (Sodium Bicarbonate Versus Saline for the Prevention of Contrast-Induced Nephropathy; NCT00606827 [ClinicalTrials.gov] )

Key Words: contrast-induced nephropathy • contrast media • angiography • angioplasty

Abbreviations and Acronyms   CI = confidence interval   CIN = contrast-induced nephropathy   NAC = N-acetylcysteine   OR = odds ratio

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