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Randomized Controlled Trial
. 2019 Dec;32(6):989-1001.
doi: 10.1007/s40620-019-00656-5. Epub 2019 Oct 9.

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

Biagio R Di Iorio  1   2 , Antonio Bellasi  3 , Kalani L Raphael  4 , Domenico Santoro  5 , Filippo Aucella  6 , Luciano Garofano  7 , Michele Ceccarelli  7   8 , Luca Di Lullo  9 , Giovanna Capolongo  10 , Mattia Di Iorio  11 , Pasquale Guastaferro  12 , Giovambattista Capasso  6   10 ; UBI Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Biagio R Di Iorio et al. J Nephrol. 2019 Dec.

Erratum in

Abstract

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.

Keywords: Chronic kidney disease; Metabolic acidosis; Sodium bicarbonate.

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Conflict of interest statement

Authors have no conflict of interest to disclose.

Figures

Fig. 1
Fig. 1
Disposition of UBI study participants
Fig. 2
Fig. 2
Serum levels of bicarbonate during the UBI study by treatment assignment. Analysis are carried out as per intention-to-treat and no data imputation on missing data is performed
Fig. 3
Fig. 3
Time to a creatinine doubling, b initiation of renal replacement therapy, and c all-cause mortality according to the Kaplan–Meyer methods (p value refers to the unadjusted log-rank tests). Analysis are carried out as per intention-to-treat and no data imputation on missing data is performed
Fig. 4
Fig. 4
Creatinine clearance during the UBI study by treatment assignment. Analysis are carried out as per intention-to-treat and no data imputation on missing data is performed
See this image and copyright information in PMC

References

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