Effect of Alkalized Urine on Renal Calculi in Patients With Gout: a Protocol for a Randomized Controlled Trial

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. Hence, it wasn't recommended by the 2020 American College of Rheumatology (ACR) guidelines. Objective: The present study aimed to determine the effect of sodium bicarbonate-alkalized urine on renal calculus in patients with gout. Methods: In 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. All patients were administered febuxostat (40 mg/day) and concomitant anti-inflammatory prophylaxis therapy. The 1–12-week group is double-blinded, and the 13–24-week group is open-labeled. The primary outcome is the rate of patients whose renal calculus volume is reduced after 12 weeks. The secondary outcomes included the volume changes of renal calculi, uric acid changes, the rate 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 adverse effects after 12 and 24 weeks.Discussion: This trial would evaluate the efficacy and safety of sodium bicarbonate-alkalized urine on renal calculi in patients with gout.Trial registration: ChiCTR, ChiCTR2100045183, Registered 7 April 2021http://www.chictr.org.cn/showproj.aspx?proj=124742

Download Full-text

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

Trials ◽

10.1186/s13063-021-05721-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ertao Jia ◽

Haiqiong Zhu ◽

Hongling Geng ◽

Yadong Wang ◽

Li Zhong ◽

...

Keyword(s):

Uric Acid ◽

Sodium Bicarbonate ◽

Ph Value ◽

Controlled Trial ◽

Renal Calculi ◽

Renal Calculus ◽

Randomized Controlled ◽

Prophylaxis Therapy ◽

Double Blinded ◽

Blinded Trial

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.

Download Full-text