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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-24-5580 | Registry Identifier | University of California, Los Angeles IRB |
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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| Brigham and Women's Hospital | OTHER |
| Landspitali University Hospital | OTHER |
| University of California, San Diego |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Bicarbonate -> Potassium Citrate | Experimental | Receives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout. |
|
| Potassium Citrate -> Sodium Bicarbonate | Experimental | 1 week of potassium citrate first, then sodium bicarbonate after a washout. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Citrate | Drug | 20 mEq Kcit twice a day (40 mEq daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection | Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention. To determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10 Unit: mg/day | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urine pH Measured from 24-Hour Urine Collection | Change in urine pH measured from 24 hour urine collections obtained at baseline and after intervention units: pH | 14 days |
| Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Side Effects | Number of participants experiencing side effects attributed to the intervention Unit: number of participants with ≥1 adverse event | 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janelly B Jimenez | Contact | JBJimenez@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kymora B Scotland, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of California, Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36261757 | Background | 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. | |
| 23602798 | Background | 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. |
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De-identified individual participant data that underlie the results reported in this study, along with the Study Protocol and Statistical Analysis Plan, will be made available to qualified researchers upon request. Interested parties should direct their inquiries and research proposals to KScotland@mednet.ucla.edu. To gain access, requestors will be required to provide a methodologically sound proposal and sign a formal Data Use Agreement (DUA) to ensure participant confidentiality. Data will be available beginning 6 months after the publication of the primary results and will remain accessible for a period of 3 years. The study team will review all requests to determine if the proposed use of the data aligns with the original study's ethical approvals and scientific objectives.
Starting 6 months after publication
Ending 3 years after publication
Researchers who submit a research proposal with justified rationale for why they need to access the data along with sound methodological approach, pending approval by the corresponding author. De-identified IPD (ie. baseline characteristics, outcomes, and adverse events) reported from this study will be made available along with study protocol and statistical analysis plan.
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| OTHER |
| Centre hospitalier de l'Université de Montréal (CHUM) | OTHER |
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| Sodium Bicarbonate | Drug | 650 mg sodium bicarbonate twice a day (35.2 mEq daily) |
|
Change in 24 hour urinary ammonia excretion from 24 hour urine collections obtained at baseline and after intervention Unit: mmol/day |
| 14 days |
| Sacramento |
| California |
| 95817 |
| United States |
|
| University of California, San Diego | San Diego | California | 92103 | United States |
|
| Brigham & Women's | Boston | Massachusetts | 02115 | United States |
|
| CHUM | Montreal | Canada |
| Landspitali- National University Hospital of Iceland | Reykjavik | Iceland |
|
| 27041472 | Background | 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. |
| 24857648 | Background | 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. |
| 10608521 | Background | 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. |
| 8230497 | Background | 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. |
| 9366314 | Background | 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. |
| 2688503 | Background | 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. |
| 22498635 | Background | Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31. |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| D053040 | Nephrolithiasis |
| D002137 | Calculi |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019357 | Potassium Citrate |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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