TY - JOUR
T1 - Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease
T2 - the UBI Study
AU - The UBI Study Group
AU - Di Iorio, Biagio R.
AU - Bellasi, Antonio
AU - Raphael, Kalani L.
AU - Santoro, Domenico
AU - Aucella, Filippo
AU - Garofano, Luciano
AU - Ceccarelli, Michele
AU - Di Lullo, Luca
AU - Capolongo, Giovanna
AU - Di Iorio, Mattia
AU - Guastaferro, Pasquale
AU - Capasso, Giovambattista
AU - Barbera, Vincenzo
AU - Bruzzese, Annamaria
AU - Canale, Valeria
AU - Conte, Giuseppe
AU - Crozza, Vincenzo
AU - Cupisti, Adamasco
AU - De Blasio, Antonella
AU - De Simone, Emanuele
AU - Di Micco, Lucia
AU - Fiorini, Fulvio
AU - Grifa, Rachele
AU - Nardone, Raffaella
AU - Piemontese, Matteo
AU - Sirico, Maria Luisa
AU - Vitale, Fabio
N1 - Publisher Copyright:
© 2019, The Author(s).
PY - 2019/12/1
Y1 - 2019/12/1
N2 - 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.
AB - 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.
KW - Chronic kidney disease
KW - Metabolic acidosis
KW - Sodium bicarbonate
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U2 - 10.1007/s40620-019-00656-5
DO - 10.1007/s40620-019-00656-5
M3 - Article
C2 - 31598912
AN - SCOPUS:85074011152
SN - 1121-8428
VL - 32
SP - 989
EP - 1001
JO - Journal of Nephrology
JF - Journal of Nephrology
IS - 6
ER -