Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones

Обзор

Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications. Prescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and/or decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied. This study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.

Подробное описание

Kidney stones affect 1 in every 11 people in the United States each year. A recurrence rate of 50% at 10 years highlights the importance of metabolic management, which has shown to be effective at decreasing the recurrence of stone disease. Specialty guidelines have recommended that clinicians offer pharmacologic therapy to recurrent stone formers. However, among kidney stone patients prescribed medication for stone management, only 30.2% are adherent to a medication regimen and even fewer, only 13.4%, are adherent with citrate medications.

Prescription potassium citrate (Kcit) can be cost-prohibitive for many patients, leading to non-compliance. The combination of the effectiveness of medication with the prohibitory cost of the prescriptions has led to the exploration of treatment alternatives which promise to alkalinize the urine and/or decrease the risk of future kidney stones, including sodium bicarbonate. However, the efficacy of these alternatives in comparison to Kcit are not well studied and often include other alkali equivalents.

A short-term study with limited sample size suggests sodium bicarbonate to be a viable alternative to Kcit. Our goal is to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of stone-forming patients and compare this to prescription Kcit.

Вмешательства

• Препарат Potassium Citrate
  20 mEq Kcit twice a day (40 mEq daily
• Препарат Sodium Bicarbonate
  650 mg sodium bicarbonate twice a day (35.2 mEq daily)

Первичные конечные точки

• Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection [Срок оценки: 14 days]

Вторичные конечные точки (2)

• Change in Urine pH Measured from 24-Hour Urine Collection [Срок оценки: 14 days]
• Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection [Срок оценки: 14 days]

Критерии участия

Критерии включения

• Adult >18 years of age
• History of nephrolithiasis
• One 24h urine collections within one year of enrollment with hypocitraturia.
• Patients currently utilizing or considering use of Kcit for stone prevention

Критерии исключения

• Individuals with known metabolic disorders
• Individuals with other known causes of nephrolithiasis
• Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• University of California, Los Angeles — Los Angeles
• University of California, Davis — Sacramento
• University of California, San Diego — San Diego
• Brigham & Women's — Boston

Канада · 1 центр

• CHUM — Montreal

Iceland · 1 центр

• Landspitali- National University Hospital of Iceland — Reykjavik

Публикации

• Xue W, Cheng J, Zhao J, Wang L, Peng A, Liu X. Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial. Int Urol Nephrol. 2023 Jan;55(1):61-68. doi: 10.1007/s11255-022-03387-y. Epub 2022 Oct 19. PMID 36261757
• Pinheiro VB, Baxmann AC, Tiselius HG, Heilberg IP. The effect of sodium bicarbonate upon urinary citrate excretion in calcium stone formers. Urology. 2013 Jul;82(1):33-7. doi: 10.1016/j.urology.2013.03.002. Epub 2013 Apr 18. PMID 23602798
• Dauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS Jr, Hollenbeck BK, Hollingsworth JM. Factors Associated With Preventive Pharmacological Therapy Adherence Among Patients With Kidney Stones. Urology. 2016 Jul;93:45-9. doi: 10.1016/j.urology.2016.03.030. Epub 2016 Mar 31. PMID 27041472
• Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR; American Urological Assocation. Medical management of kidney stones: AUA guideline. J Urol. 2014 Aug;192(2):316-24. doi: 10.1016/j.juro.2014.05.006. Epub 2014 May 20. PMID 24857648
• Pearle MS, Roehrborn CG, Pak CY. Meta-analysis of randomized trials for medical prevention of calcium oxalate nephrolithiasis. J Endourol. 1999 Nov;13(9):679-85. doi: 10.1089/end.1999.13.679. PMID 10608521
• Barcelo P, Wuhl O, Servitge E, Rousaud A, Pak CY. Randomized double-blind study of potassium citrate in idiopathic hypocitraturic calcium nephrolithiasis. J Urol. 1993 Dec;150(6):1761-4. doi: 10.1016/s0022-5347(17)35888-3. PMID 8230497
• Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2. PMID 9366314
• Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006. PMID 2688503

Идентификаторы

NCT: NCT07408076 · IRB-24-5580 · IRB-24-5580

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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