Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate: A Randomized Controlled Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 291; no. 19; pp. 2328 - 2334
• Main Authors: Merten, Gregory J, Burgess, W. Patrick, Gray, Lee V, Holleman, Jeremiah H, Roush, Timothy S, Kowalchuk, Glen J, Bersin, Robert M, Van Moore, Arl, Simonton III, Charles A, Rittase, Robert A, Norton, H. James, Kennedy, Thomas P
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Medical Association 19.05.2004
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Clinical trials; Contrast Media - adverse effects; Creatinine - blood; Disease; Drug toxicity and drugs side effects treatment; Female; Glomerular Filtration Rate; Humans; Iopamidol - adverse effects; Kidneys; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Preventive medicine; Prospective Studies; Radiography; Rehydration Solutions - therapeutic use; Renal Insufficiency - chemically induced; Renal Insufficiency - prevention & control; Sodium; Sodium Bicarbonate - therapeutic use; Sodium Chloride - therapeutic use; Toxicity: urogenital system; Water-Electrolyte Balance; Kidney disease; Human; Medicine; Prevention; Urinary system disease; Nephropathy; Sodium; Toxicity; Clinical trial; Kidney; Hydrogencarbonates
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.291.19.2328

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.