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A Randomized Controlled Trial

Gregory J. Merten, MD; W. Patrick Burgess, MD, PhD; Lee V. Gray, MD; Jeremiah H. Holleman, MD; Timothy S. Roush, MD; Glen J. Kowalchuk, MD; Robert M. Bersin, MD; Arl Van Moore, MD; Charles A. Simonton III, MD; Robert A. Rittase, PharmD; H. James Norton, PhD; Thomas P. Kennedy, MD, MPH

JAMA. 2004;291:2328-2334.

Context  Contrast-induced nephropathy remains a common complication of radiographic procedures. Pretreatment with sodium bicarbonate is more protective than sodium chloride in animal models of acute ischemic renal failure. Acute renal failure from both ischemia and contrast are postulated to occur from free-radical injury. However, no studies in humans or animals have evaluated the efficacy of sodium bicarbonate for prophylaxis against contrast-induced nephropathy.

Objective  To examine the efficacy of sodium bicarbonate compared with sodium chloride for preventive hydration before and after radiographic contrast.

Design, Setting, and Patients  A prospective, single-center, randomized trial conducted from September 16, 2002, to June 17, 2003, of 119 patients with stable serum creatinine levels of at least 1.1 mg/dL (97.2 µmol/L) who were randomized to receive a 154-mEq/L infusion of either sodium chloride (n = 59) or sodium bicarbonate (n = 60) before and after iopamidol administration (370 mg iodine/mL). Serum creatinine levels were measured at baseline and 1 and 2 days after contrast.

Interventions  Patients received 154 mEq/L of either sodium chloride or sodium bicarbonate, as a bolus of 3 mL/kg per hour for 1 hour before iopamidol contrast, followed by an infusion of 1 mL/kg per hour for 6 hours after the procedure.

Main Outcome Measure  Contrast-induced nephropathy, defined as an increase of 25% or more in serum creatinine within 2 days of contrast.

Results  There were no significant group differences in age, sex, incidence of diabetes mellitus, ethnicity, or contrast volume. Baseline serum creatinine was slightly higher but not statistically different in patients receiving sodium bicarbonate treatment (mean [SD], 1.71 [0.42] mg/dL [151.2 {37.1} µmol/L] for sodium chloride and 1.89 [0.69] mg/dL [167.1 {61.0} µmol/L] for sodium bicarbonate; P = .09). The primary end point of contrast-induced nephropathy occurred in 8 patients (13.6%) infused with sodium chloride but in only 1 (1.7%) of those receiving sodium bicarbonate(mean difference, 11.9%; 95% confidence interval [CI], 2.6%-21.2%; P = .02). A follow-up registry of 191 consecutive patients receiving prophylactic sodium bicarbonate and meeting the same inclusion criteria as the study resulted in 3 cases of contrast-induced nephropathy (1.6%; 95% CI, 0%-3.4%).

Conclusion  Hydration with sodium bicarbonate before contrast exposure is more effective than hydration with sodium chloride for prophylaxis of contrast-induced renal failure.

Author Affiliations: Departments of Internal Medicine (Drs Merten, Gray, and Kennedy), Radiology (Dr Van Moore), Clinical Pharmacy (Dr Rittase), Biostatistics (Dr Norton), Sanger Cardiology (Drs Kowalchuk, Bersin, and Simonton), Sanger Cardiovascular Surgery (Drs Holleman and Roush), and Metrolina Nephrology (Dr Burgess), Carolinas Medical Center, Charlotte, NC. Dr Merten is now with the Division of Nephrology, Mayo Clinic, Rochester, Minn.

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