Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial

JAMA. 2008 Sep 3;300(9):1038-46. doi: 10.1001/jama.300.9.1038.

Abstract

Context: Sodium bicarbonate has been suggested as a possible strategy for prevention of contrast medium-induced nephropathy, a common cause of renal failure associated with prolonged hospitalization, increased health care costs, and substantial morbidity and mortality.

Objective: To determine if sodium bicarbonate is superior to sodium chloride for preventing contrast medium-induced nephropathy in patients with moderate to severe chronic kidney dysfunction who are undergoing coronary angiography.

Design, setting, and patients: Randomized, controlled, single-blind study conducted between January 2, 2006, and January 31, 2007, and enrolling 353 patients with stable renal disease who were undergoing coronary angiography at a single US center. Included patients were 18 years or older and had an estimated glomerular filtration rate of 60 mL/min per 1.73 m(2) or less and 1 or more of diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years.

Interventions: Patients were randomized to receive either sodium chloride (n = 178) or sodium bicarbonate (n = 175) administered at the same rate (3 mL/kg for 1 hour before coronary angiography, decreased to 1.5 mL/kg per hour during the procedure and for 4 hours after the completion of the procedure).

Main outcome measure: The primary end point was a 25% or greater decrease in the estimated glomerular filtration rate on days 1 through 4 after contrast exposure.

Results: Median patient age was 71 (interquartile range, 65-76) years, and 45% had diabetes mellitus. The groups were well matched for baseline characteristics. The primary end point was met in 13.3% of the sodium bicarbonate group and 14.6% of the sodium chloride group (relative risk, 0.94; 95% confidence interval, 0.55-1.60; P = .82). In patients randomized to receive sodium bicarbonate vs sodium chloride, the rates of death, dialysis, myocardial infarction, and cerebrovascular events did not differ significantly at 30 days (1.7% vs 1.7%, 0.6% vs 1.1%, 0.6% vs 0%, and 0% vs 2.2%, respectively) or at 30 days to 6 months (0.6% vs 2.3%, 0.6% vs 1.1%, 0.6% vs 2.3%, and 0.6% vs 1.7%, respectively) (P > .10 for all).

Conclusion: The results of this study do not suggest that hydration with sodium bicarbonate is superior to hydration with sodium chloride for the prevention of contrast medium-induced nephropathy in patients with moderate to severe chronic kidney disease who are undergoing coronary angiography.

Trial registration: clinicaltrials.gov Identifier: NCT00312117.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Contrast Media / adverse effects*
  • Coronary Angiography*
  • Diabetes Mellitus / epidemiology
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Iohexol / adverse effects
  • Iohexol / analogs & derivatives
  • Iopamidol / adverse effects
  • Male
  • Renal Insufficiency / chemically induced*
  • Renal Insufficiency / epidemiology
  • Renal Insufficiency / prevention & control*
  • Renal Insufficiency, Chronic* / epidemiology
  • Risk Factors
  • Single-Blind Method
  • Sodium Bicarbonate / administration & dosage*
  • Sodium Chloride / administration & dosage*

Substances

  • Contrast Media
  • Iohexol
  • Sodium Chloride
  • Sodium Bicarbonate
  • ioxilan
  • Iopamidol

Associated data

  • ClinicalTrials.gov/NCT00312117