Do intravenous N-acetylcysteine and sodium bicarbonate prevent high osmolal contrast-induced acute kidney injury? A randomized controlled trial

PLoS One. 2014 Sep 25;9(9):e107602. doi: 10.1371/journal.pone.0107602. eCollection 2014.

Abstract

Background: N-acetylcysteine (NAC) or sodium bicarbonate (NaHCO3), singly or combined, inconsistently prevent patients exposed to radiographic contrast media from developing contrast-induced acute kidney injury (CI-AKI).

Objective: We asked whether intravenous isotonic saline and either NaHCO3 in 5% dextrose or else a high dose of NAC in 5% dextrose prevent CI-AKI in outpatients exposed to high-osmolal iodinated contrast medium more than does saline alone.

Methods: This completed prospective, parallel, superiority, open-label, controlled, computer-randomized, single-center, Brazilian trial (NCT01612013) hydrated 500 adult outpatients (214 at high risk of developing CI-AKI) exposed to ioxitalamate during elective coronary angiography and ventriculography. From 1 hour before through 6 hours after exposure, 126 patients (group 1) received a high dose of NAC and saline, 125 (group 2) received NaHCO3 and saline, 124 (group 3) received both treatments, and 125 (group 4) received only saline.

Results: Groups were similar with respect to age, gender, weight, pre-existing renal dysfunction, hypertension, medication, and baseline serum creatinine and serum cystatin C, but diabetes mellitus was significantly less prevalent in group 1. CI-AKI incidence 72 hours after exposure to contrast medium was 51.4% (257/500), measured as serum creatinine > (baseline+0.3 mg/dL) and/or serum cystatin C > (1.1 · baseline), and 7.6% (38/500), measured as both serum creatinine and serum cystatin C > (baseline+0.3 mg/dL) or > (1.25 · baseline). CI-AKI incidence measured less sensitively was similar among groups. Measured more sensitively, incidence in group 1 was significantly (p<0.05) lower than in groups 2 and 3 but not group 4; adjustment for confounding by infused volume equalized incidence in groups 1 and 3.

Conclusion: We found no evidence that intravenous isotonic saline and either NaHCO3 or else a high dose of NAC prevent CI-AKI in outpatients exposed to high osmolal iodinated contrast medium more than does saline alone.

Trial registration: ClinicalTrials.gov NCT01612013.

Publication types

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

MeSH terms

  • Acetylcysteine / administration & dosage*
  • Acetylcysteine / pharmacology*
  • Acute Kidney Injury / chemically induced*
  • Acute Kidney Injury / prevention & control*
  • Administration, Intravenous
  • Contrast Media / adverse effects*
  • Contrast Media / chemistry
  • Coronary Angiography / adverse effects
  • Female
  • Humans
  • Iothalamic Acid / adverse effects
  • Iothalamic Acid / analogs & derivatives
  • Iothalamic Acid / chemistry
  • Male
  • Middle Aged
  • Osmolar Concentration
  • Sodium Bicarbonate / administration & dosage*
  • Sodium Bicarbonate / pharmacology*

Substances

  • Contrast Media
  • Iothalamic Acid
  • Sodium Bicarbonate
  • ioxitalamic acid
  • Acetylcysteine

Associated data

  • ClinicalTrials.gov/NCT01612013

Grants and funding

The authors, Hospital das Forças Armadas e Instituto de Cardiologia de Brasília funding the work. All drugs were bought by principal investigator and Hospital das Forças Armadas. The laboratory analysis were done without costs by Hospital das Forças Armadas de Brasília. The coronary angiography was performed at Instituto de Cardiologia de Brasília. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.