title: A randomized comparison of 1-h sodium bicarbonate hydration versus standard peri-procedural saline hydration in patients with chronic kidney disease undergoing intravenous contrast-enhanced computerized tomography.
abstract: BACKGROUND
  Guidelines recommend saline hydration for prophylaxis of contrast-induced acute kidney injury (CI-AKI) in patients with chronic kidney disease (CKD) undergoing intravenous contrast media-enhanced CT (CE-CT). The safety and efficacy of a brief hydration protocol using sodium bicarbonate in this population is unknown. We analysed whether 1-h sodium bicarbonate hydration prior to CE-CT is non-inferior to saline hydration prior to and after CE-CT in CKD patients.
  
  
  METHODS
  We performed an open-label multicentre randomized trial. Patients were randomized to 250 mL of 1.4% sodium bicarbonate hydration prior to CE-CT or 1000 mL of 0.9% saline hydration prior to and, once again, after CE-CT. Primary outcome was the relative increase in serum creatinine 48-96 h post-CE-CT. Secondary outcomes were incidence of CI-AKI [serum creatinine increase >25%/>44 µmol/L (0.5 mg/dL)], recovery of renal function, the need for dialysis and 2-month hospital costs.
  
  
  RESULTS
  Five hundred and seventy adult CKD patients undergoing CE-CT were randomized between 2010 and 2012, of whom 548 were included in the intention-to-treat population. Mean relative serum creatinine increase was 1.2% for sodium bicarbonate and 1.5% for saline (mean difference -0.3%; 95% confidence interval -2.7 to 2.1, P-value for non-inferiority <0.0001). CI-AKI occurred in 22 patients (4.1%); 8 (3.0%) randomized to sodium bicarbonate versus 14 (5.1%) to saline (P = 0.23). Renal function recovered in 75 and 69% of CI-AKI patients, respectively (P = 0.81). No patients developed a need for dialysis. Mean hydration costs per patient were €224 for the sodium bicarbonate and €683 for the saline regime (P < 0.001). Other healthcare costs were similar.
  
  
  CONCLUSIONS
  Short hydration with sodium bicarbonate prior to CE-CT was non-inferior to peri-procedural saline hydration with respect to renal safety and may result in healthcare savings. [Netherlands Trial Register (http://www.trialregister.nl/trialreg/index.asp), Nr 2149, date of registration 23 December 2009.].
authors.affiliation: Department of Thrombosis and Haemostasis, Einthoven Laboratory for Experimental Vascular Medicine, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Judith
authors.initials: J
authors.lastname: Kooiman
authors.forename: Yvo W J
authors.initials: YW
authors.lastname: Sijpkens
authors.forename: Jean-Paul P M
authors.initials: JP
authors.lastname: de Vries
authors.forename: Harald F H
authors.initials: HF
authors.lastname: Brulez
authors.forename: Jaap F
authors.initials: JF
authors.lastname: Hamming
authors.forename: Aart J
authors.initials: AJ
authors.lastname: van der Molen
authors.forename: Nico J M
authors.initials: NJ
authors.lastname: Aarts
authors.forename: Suzanne C
authors.initials: SC
authors.lastname: Cannegieter
authors.forename: Hein
authors.initials: H
authors.lastname: Putter
authors.forename: Renate
authors.initials: R
authors.lastname: Swarts
authors.forename: Wilbert B
authors.initials: WB
authors.lastname: van den Hout
authors.forename: Ton J
authors.initials: TJ
authors.lastname: Rabelink
authors.forename: Menno V
authors.initials: MV
authors.lastname: Huisman
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D003287:Contrast Media; D003404:Creatinine / Q000097:blood; D005260:Female; D005440:Fluid Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D051436:Renal Insufficiency, Chronic / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D017693:Sodium Bicarbonate / Q000008:administration & dosage*; D012965:Sodium Chloride / Q000008:administration & dosage*; D014057:Tomography, X-Ray Computed
chemical_list: D003287:Contrast Media; D012965:Sodium Chloride; D017693:Sodium Bicarbonate; D003404:Creatinine
keywords: acute renal failure; chronic kidney disease; contrast induced-acute kidney injury; prevention; randomized controlled trial