TY - JOUR
T1 - A prospective, multicenter, randomized, controlled study
T2 - The Correction of Metabolic Acidosis with Use of Bicarbonate in Chronic Renal Insufficiency (UBI) Study
AU - Di Iorio, Biagio
AU - Aucella, Filippo
AU - Conte, Giuseppe
AU - Cupisti, Adamasco
AU - Santoro, Domenico
PY - 2012/6
Y1 - 2012/6
N2 - 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.
AB - 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.
KW - Chronic kidney disease
KW - Metabolic acidosis
KW - Morbility
KW - Mortality
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UR - http://www.scopus.com/inward/citedby.url?scp=84863300339&partnerID=8YFLogxK
U2 - 10.5301/jn.5000014
DO - 10.5301/jn.5000014
M3 - Article
C2 - 21928233
AN - SCOPUS:84863300339
VL - 25
SP - 437
EP - 440
JO - Journal of Nephrology
JF - Journal of Nephrology
SN - 1121-8428
IS - 3
ER -