title: Prevention of contrast-induced nephropathy in diabetic patients with impaired renal function: a randomized, double blind trial of sodium bicarbonate versus sodium chloride-based hydration.
abstract: OBJECTIVE
  Diabetes mellitus and decreased renal function are important risk factors for contrast-induced nephropathy (CIN) in which oxidative stress damage may play a role. Alkalinization with sodium bicarbonate (NaHCO₃) has been proposed as a means of reducing free-radical mediated renal injury; however, the effectiveness of NaHCO₃ treatment to prevent CIN in high-risk patients remains uncertain.
  
  
  METHODS
  We performed a prospective, randomized, double blind, sodium chloride (NaCl) hydration-controlled study of NaHCO₃ in 120 diabetic patients with impaired renal function (serum creatinine ≥100 μmol/L) undergoing an elective procedure with use of low-osmolar contrast media. The primary endpoint was the incidence of CIN defined as creatinine increase of ≥25% and/or ≥44 μmol/L within 2 days after contrast. Secondary end-points were maximal changes in serum creatinine and estimated glomerular filtration rate. Urine F₂-isoprostane levels were also assessed as measure of oxidative stress.
  
  
  RESULTS
  There were no significant group differences in baseline characteristics except for the marginally lower age of the NaHCO₃ treated patients (63 ± 11 vs. 67 ± 10 years; p=0.05). CIN occurred in 7 (11.5%) and 5 (8.5%) patients of the NaHCO₃ and NaCl groups, respectively (p=0.76; incidence rate ratio 1.35; 95% CI 0.37-5.41). No significant differences were seen in secondary outcome measures and changes in the parameter of oxidative stress.
  
  
  CONCLUSIONS
  In diabetic patients with renal function impairment sodium bicarbonate does not confer protection against contrast-induced nephropathy greater than sodium chloride-based hydration. Its specific role in mitigating oxidative stress damage in CIN is also not supported by our data.
authors.affiliation: Diabetes Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. Electronic address: petr.boucek@ikem.cz.
authors.forename: Petr
authors.initials: P
authors.lastname: Boucek
authors.forename: Terezia
authors.initials: T
authors.lastname: Havrdova
authors.forename: Olena
authors.initials: O
authors.lastname: Oliyarnyk
authors.forename: Jelena
authors.initials: J
authors.lastname: Skibova
authors.forename: Vera
authors.initials: V
authors.lastname: Pecenkova
authors.forename: Tereza
authors.initials: T
authors.lastname: Pucelikova
authors.forename: Darina
authors.initials: D
authors.lastname: Sarkady
mesh_terms: D000368:Aged; D003287:Contrast Media / Q000009:adverse effects; D003928:Diabetic Nephropathies / Q000139:chemically induced / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017693:Sodium Bicarbonate / Q000627:therapeutic use*; D012965:Sodium Chloride / Q000627:therapeutic use*
chemical_list: D003287:Contrast Media; D012965:Sodium Chloride; D017693:Sodium Bicarbonate
keywords: Contrast-induced nephropathy; Diabetes mellitus; Impaired renal function; Sodium bicarbonate