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Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study

BACKGROUND: Metabolic acidosis is associated with accelerated progression of chronic kidney disease (CKD). Whether treatment of metabolic acidosis with sodium bicarbonate improves kidney and patient survival in CKD is unclear. METHODS: We conducted a randomized (ratio 1:1). open-label, controlled tr...

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Autores principales: Di Iorio, Biagio R., Bellasi, Antonio, Raphael, Kalani L., Santoro, Domenico, Aucella, Filippo, Garofano, Luciano, Ceccarelli, Michele, Di Lullo, Luca, Capolongo, Giovanna, Di Iorio, Mattia, Guastaferro, Pasquale, Capasso, Giovambattista
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6821658/
https://www.ncbi.nlm.nih.gov/pubmed/31598912
http://dx.doi.org/10.1007/s40620-019-00656-5
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author Di Iorio, Biagio R.
Bellasi, Antonio
Raphael, Kalani L.
Santoro, Domenico
Aucella, Filippo
Garofano, Luciano
Ceccarelli, Michele
Di Lullo, Luca
Capolongo, Giovanna
Di Iorio, Mattia
Guastaferro, Pasquale
Capasso, Giovambattista
author_facet Di Iorio, Biagio R.
Bellasi, Antonio
Raphael, Kalani L.
Santoro, Domenico
Aucella, Filippo
Garofano, Luciano
Ceccarelli, Michele
Di Lullo, Luca
Capolongo, Giovanna
Di Iorio, Mattia
Guastaferro, Pasquale
Capasso, Giovambattista
author_sort Di Iorio, Biagio R.
collection PubMed
description BACKGROUND: Metabolic acidosis is associated with accelerated progression of chronic kidney disease (CKD). Whether treatment of metabolic acidosis with sodium bicarbonate improves kidney and patient survival in CKD is unclear. METHODS: We conducted a randomized (ratio 1:1). open-label, controlled trial (NCT number: NCT01640119. www.clinicaltrials.gov) to determine the effect in patients with CKD stage 3–5 of treatment of metabolic acidosis with sodium bicarbonate (SB) on creatinine doubling (primary endpoint), all-cause mortality and time to renal replacement therapy compared to standard care (SC) over 36-months. Parametric, non-parametric tests and survival analyses were used to assess the effect of SB on these outcomes. RESULTS: A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol/l were enrolled in SB and SC, respectively. Mean (SD) follow-up was 29.6 (9.8) vs 30.3 (10.7) months in SC and SB. respectively. The mean (SD) daily doses of SB was 1.13 (0.10). 1.12 (0.11). and 1.09 (0.12) mmol/kg*bw/day in the first, second and third year of follow-up, respectively. A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001). Similarly, 71 participants [45 (12.3%) in SC and 26 (6.9%) in SB, p = 0.016] started dialysis while 37 participants [25 (6.8%) in SC and 12 (3.1%) in SB, p = 0.004] died. There were no significant effect of SB on blood pressure, total body weight or hospitalizations. CONCLUSION: In persons with CKD 3–5 without advanced stages of chronic heart failure, treatment of metabolic acidosis with sodium bicarbonate is safe and improves kidney and patient survival. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40620-019-00656-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-68216582019-11-06 Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study Di Iorio, Biagio R. Bellasi, Antonio Raphael, Kalani L. Santoro, Domenico Aucella, Filippo Garofano, Luciano Ceccarelli, Michele Di Lullo, Luca Capolongo, Giovanna Di Iorio, Mattia Guastaferro, Pasquale Capasso, Giovambattista J Nephrol Original Article BACKGROUND: Metabolic acidosis is associated with accelerated progression of chronic kidney disease (CKD). Whether treatment of metabolic acidosis with sodium bicarbonate improves kidney and patient survival in CKD is unclear. METHODS: We conducted a randomized (ratio 1:1). open-label, controlled trial (NCT number: NCT01640119. www.clinicaltrials.gov) to determine the effect in patients with CKD stage 3–5 of treatment of metabolic acidosis with sodium bicarbonate (SB) on creatinine doubling (primary endpoint), all-cause mortality and time to renal replacement therapy compared to standard care (SC) over 36-months. Parametric, non-parametric tests and survival analyses were used to assess the effect of SB on these outcomes. RESULTS: A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol/l were enrolled in SB and SC, respectively. Mean (SD) follow-up was 29.6 (9.8) vs 30.3 (10.7) months in SC and SB. respectively. The mean (SD) daily doses of SB was 1.13 (0.10). 1.12 (0.11). and 1.09 (0.12) mmol/kg*bw/day in the first, second and third year of follow-up, respectively. A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001). Similarly, 71 participants [45 (12.3%) in SC and 26 (6.9%) in SB, p = 0.016] started dialysis while 37 participants [25 (6.8%) in SC and 12 (3.1%) in SB, p = 0.004] died. There were no significant effect of SB on blood pressure, total body weight or hospitalizations. CONCLUSION: In persons with CKD 3–5 without advanced stages of chronic heart failure, treatment of metabolic acidosis with sodium bicarbonate is safe and improves kidney and patient survival. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40620-019-00656-5) contains supplementary material, which is available to authorized users. Springer International Publishing 2019-10-09 2019 /pmc/articles/PMC6821658/ /pubmed/31598912 http://dx.doi.org/10.1007/s40620-019-00656-5 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Di Iorio, Biagio R.
Bellasi, Antonio
Raphael, Kalani L.
Santoro, Domenico
Aucella, Filippo
Garofano, Luciano
Ceccarelli, Michele
Di Lullo, Luca
Capolongo, Giovanna
Di Iorio, Mattia
Guastaferro, Pasquale
Capasso, Giovambattista
Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study
title Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study
title_full Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study
title_fullStr Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study
title_full_unstemmed Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study
title_short Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study
title_sort treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the ubi study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6821658/
https://www.ncbi.nlm.nih.gov/pubmed/31598912
http://dx.doi.org/10.1007/s40620-019-00656-5
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