title: Do intravenous N-acetylcysteine and sodium bicarbonate prevent high osmolal contrast-induced acute kidney injury? A randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01612013.
authors.affiliation: Divisão de Nefrologia, Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brazil.
authors.forename: Antonio Jose
authors.initials: AJ
authors.lastname: Inda-Filho
authors.affiliation: Cardiologia, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.
authors.forename: Adriano
authors.initials: A
authors.lastname: Caixeta
authors.affiliation: Cardiologia, Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brazil.
authors.forename: Marcia
authors.initials: M
authors.lastname: Manggini
authors.affiliation: Pós Graduação em Nefrologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.
authors.forename: Nestor
authors.initials: N
authors.lastname: Schor
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage* / Q000494:pharmacology*; D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000517:prevention & control*; D061605:Administration, Intravenous; D003287:Contrast Media / Q000009:adverse effects* / Q000737:chemistry; D017023:Coronary Angiography / Q000009:adverse effects; D005260:Female; D006801:Humans; D007483:Iothalamic Acid / Q000009:adverse effects / Q000031:analogs & derivatives / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D017693:Sodium Bicarbonate / Q000008:administration & dosage* / Q000494:pharmacology*
chemical_list: D003287:Contrast Media; D007483:Iothalamic Acid; D017693:Sodium Bicarbonate; C002587:ioxitalamic acid; D000111:Acetylcysteine