NDLI: Effect of alkalized urine on renal calculi in patients with gout: a protocol for a placebo-controlled, double-blinded randomized controlled trial

Content Provider	Springer Nature : BioMed Central
Author	Jia, Ertao Zhu, Haiqiong Geng, Hongling Wang, Yadong Zhong, Li Liu, Shangwen Lin, Feng Zhang, Jianyong
Abstract	Background The prevalence of renal calculi in patients with gout is high. Alkalized urine has been recommended by the 2020 European Association of Urology (EAU) guidelines to promote calculus dissolution. However, randomized controlled trials are lacking. Methods In the protocol of this randomized, placebo-controlled, double-blinded trial, patients with gout combined with renal calculi are randomized (1:1) to the placebo and sodium bicarbonate groups. The intervention would be performed for 24 weeks, the 1–12 weeks are double-blinded, and the 13–24 weeks are open-labeled. Sodium bicarbonate (1 g tid) will be performed for 24 weeks in the sodium bicarbonate group. The placebo will be performed for 12 weeks and not be performed from 13 weeks to 24 weeks in the placebo group. All subjects will be administered febuxostat (40 mg/day) for 24 weeks and receive concomitant anti-inflammatory prophylaxis therapy for 12 weeks. The primary outcome is the proportion of patients whose renal calculus volume will be reduced after 12 weeks of treatment. The secondary outcomes include the volume changes of renal calculi, uric acid changes, the proportion of patients with serum uric acid (sUA) levels < 360 μmol/L, the changes in estimated glomerular filtration rate (eGFR), the pH value of urine, and the incidence of adverse events after treatment for 12 and 24 weeks. Discussion This study will evaluate the efficacy and safety of sodium bicarbonate-alkalized urine on renal calculi in patients with gout. Trial registration ClinicalTrials.gov ChiCTR2100045183. Registered on April 7, 2021, with ChiCTR.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-021-05721-8.pdf
Ending Page	10
Page Count	10
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-021-05721-8
Journal	Trials
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2021-10-26
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Gout Renal calculus Urine alkalization Sodium bicarbonate Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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