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.
RCT Entities:
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-ESRDpatients. 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 ESRDpatients.
Authors: Kalani L Raphael; Tamara Isakova; Joachim H Ix; Dominic S Raj; Myles Wolf; Linda F Fried; Jennifer J Gassman; Cynthia Kendrick; Brett Larive; Michael F Flessner; Susan R Mendley; Thomas H Hostetter; Geoffrey A Block; Ping Li; John P Middleton; Stuart M Sprague; Donald E Wesson; Alfred K Cheung Journal: J Am Soc Nephrol Date: 2019-12-17 Impact factor: 10.121
Authors: Miles D Witham; Margaret Band; Huey Chong; Peter T Donnan; Geeta Hampson; May Khei Hu; Roberta Littleford; Edmund Lamb; Philip A Kalra; Gwen Kennedy; Paul McNamee; Deirdre Plews; Petra Rauchhaus; Roy L Soiza; Deepa Sumukadas; Graham Warwick; Alison Avenell Journal: Health Technol Assess Date: 2020-06 Impact factor: 4.014
Authors: Teclegiorgis Gebremariam; Lin Lin; Mingfu Liu; Dimitrios P Kontoyiannis; Samuel French; John E Edwards; Scott G Filler; Ashraf S Ibrahim Journal: J Clin Invest Date: 2016-05-09 Impact factor: 14.808
Authors: María M Adeva-Andany; Carlos Fernández-Fernández; David Mouriño-Bayolo; Elvira Castro-Quintela; Alberto Domínguez-Montero Journal: ScientificWorldJournal Date: 2014-10-21
Authors: Miles D Witham; Margaret M Band; Roberta C Littleford; Alison Avenell; Roy L Soiza; Marion E T McMurdo; Deepa Sumukadas; Simon A Ogston; Edmund J Lamb; Geeta Hampson; Paul McNamee Journal: Trials Date: 2015-08-01 Impact factor: 2.279