title: Prevention of contrast induced nephropathy with sodium bicarbonate (the PROMEC study).
abstract: BACKGROUND
  Contrast-induced nephropathy is a common complication of radiographic procedures. Different measures have been used to avoid this damage, but the evidence is controversial. New investigations are required to clarify it. We investigated the efficacy and safety of sodium bicarbonate solution compared with sodium chloride solution to prevent contrast induced nephropathy in patients with or at risk of renal dysfunction.
  
  
  METHODS
  A prospective, single-center, randomized clinical trial conducted from May 1, 2007 to February 8, 2008. Inpatients in a tertiary center, scheduled to undergo a procedure with the nonionic radiographic contrast agent iohexol. There were 220 patients with serum creatinine levels of at least 1.2 mg/dL (106.1 µmol/L) and/or type 2 diabetics, who were randomized to receive an infusion of sodium chloride (n = 113) or sodium bicarbonate (n = 107) before and after contrast dye administration. The intervention were "A" group received 1 ml/kg/hour of normal saline solution, starting 12 hours before and continuing 12 hours after iohexol contrast. "B" group received 3 ml/kg of sodium bicarbonate solution (150 mEq/L) one hour prior to procedure and then drip rate was decreased to 1 ml/kg/hour until 6 hours post procedure. Our main outcome measure was change in serum creatinine.
  
  
  RESULTS
  The mean creatinine value after the procedure was 1.26 mg/dL in the saline group and 1.22 mg/dL in the bicarbonate group (mean difference: 0.036; CI 95%: -0.16 to 0.23, p = 0.865). The diagnosis of contrast-induced nephropathy, defined by increase in serum creatinine on 25% or more within 2 days after administration of radiographic contrast, was done in twelve patients (12%) in the bicarbonate group and eighth patients (7.1%) in the saline group (RR: 1.68, CI 95%: 0.72 to 3.94).
  
  
  CONCLUSIONS
  Our investigation showed that there were no differences between normal saline solution (extended infusion) vs. bicarbonate solution for nephroprotection.
authors.affiliation: Hospital Pablo Tobón Uribe.
authors.forename: John Fredy
authors.initials: JF
authors.lastname: Nieto-Ríos
authors.affiliation: Universidade de Antioquia.
authors.forename: Wílmar Arley Maya
authors.initials: WA
authors.lastname: Salazar
authors.affiliation: Hospital Pablo Tobón Uribe.
authors.forename: Oscar Mauricio Santos
authors.initials: OM
authors.lastname: Sánchez
authors.affiliation: Universidade de Antioquia.
authors.forename: Janeth Liliana Jaramillo
authors.initials: JL
authors.lastname: Ortega
authors.affiliation: Universidade de Antioquia.
authors.forename: Jorge Ignacio García
authors.initials: JI
authors.lastname: Caro
authors.affiliation: Universidade de Antioquia.
authors.forename: Julián Miguel Aristizabal
authors.initials: JM
authors.lastname: Aristizabal
authors.affiliation: Hospital Pablo Tobón Uribe.
authors.forename: Lina Maria Serna
authors.initials: LM
authors.lastname: Higuita
authors.affiliation: Universidade de Antioquia.
authors.forename: Álvaro García
authors.initials: ÁG
authors.lastname: García
authors.affiliation: Hospital Pablo Tobón Uribe.
authors.forename: Fabián Alberto Jaimes
authors.initials: FA
authors.lastname: Barragán
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007674:Kidney Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D017693:Sodium Bicarbonate / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D003287:Contrast Media; D017693:Sodium Bicarbonate