title: A prospective, multicenter, randomized, controlled study: the correction of metabolic acidosis with use of bicarbonate in Chronic Renal Insufficiency (UBI) Study.
abstract: BACKGROUND
  A Cochrane Collaboration review (Roderick, Cochrane Data base of systemic reviews 2007, DOI 10.1002/14651858.CD0018.90.pub3) reported that there was no evidence for correction of acidosis by sodium bicarbonate in pre-end-stage renal disease (ESRD) patients, and concluded that randomized controlled trials (RCTs) are necessary to evaluate the benefits and harms of correcting metabolic acidosis in pre-ESRD patients. We wanted to evaluate if the administration of alcaly (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce mortality due to cardiovascular events.
  
  
  METHODS
  This is a proposal for a multicenter, prospective, cohort, randomized and controlled study. We will randomize 600 patients with chronic kidney disease (CKD) stages 3b and 4; 300 of these patients will be included in the bicarbonate study group (Bic), in which levels of bicarbonate should be kept >24 mEq/L; the other 300 patients will be included in the usual-treatment group (no-Bic).
  
  
  RESULTS
  The aim of the research protocol is to demonstrate whether the optimal correction of uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing agent - e.g., sodium citrate) reduces renal and cardiovascular mortality.
  
  
  CONCLUSIONS
  In conclusion, the Work Group on Conservative Therapy for Chronic Renal Insufficiency proposes this prospective, multicenter, cohort, randomized, controlled study to evaluate the effects of correction of acidosis on the progression of the kidney disease evaluated as renal death in ESRD patients.
authors.affiliation: SOC di Nefrologia, A. Landolfi Hospital, Solofra, Avellino, Italy. br.diiorio@libero.it
authors.forename: Biagio
authors.initials: B
authors.lastname: Di Iorio
authors.forename: Filippo
authors.initials: F
authors.lastname: Aucella
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Conte
authors.forename: Adamasco
authors.initials: A
authors.lastname: Cupisti
authors.forename: Domenico
authors.initials: D
authors.lastname: Santoro
mesh_terms: D000138:Acidosis / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D007558:Italy; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D012107:Research Design; D017693:Sodium Bicarbonate / Q000097:blood / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D017693:Sodium Bicarbonate