Urinary supersaturation in a Randomized trial among Individuals with Nephrolithiasis comparing Empiric versus selective therapy (URINE): design and rationale of a clinical trial
Tóm tắt
Clinical guidelines disagree on whether the identification of abnormal urine chemistries should occur before starting diet and medication interventions to prevent the recurrence of kidney stone events. We describe the rationale and design of the Urinary supersaturation in a Randomized trial among Individuals with Nephrolithiasis comparing Empiric versus selective therapy (URINE) study, a randomized trial comparing two multi-component interventions to improve urinary supersaturation. Participants are randomized (1:1 ratio) to the empiric or selective arm. The target sample size is 56 participants. Adults ≥ 18 years of age with idiopathic calcium stone disease and two symptomatic stone events within the previous 5 years. Exclusion criteria include systemic conditions predisposing to kidney stones and pharmacologic treatment for stone prevention at baseline. Participants in the empiric arm receive standard diet therapy recommendations, thiazide, and potassium citrate. Participants in the selective arm receive tailored diet and nutrient recommendations and medications based on baseline and 1-month follow-up of 24-h urine testing results. The primary endpoints are urinary supersaturations of calcium oxalate and calcium phosphate at 2 months of follow-up. Secondary endpoints include side effects, diet and medication adherence, and changes in 24-h urine volume, calcium, oxalate, citrate, and pH. Short-term changes in urinary supersaturation may not reflect changes in future risk of stone events. The URINE study will provide foundational data to compare the effectiveness of two prevention strategies for kidney stone disease.
Tài liệu tham khảo
Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR (2014) American urological, Medical management of kidney stones: AUA guideline. J Urol 192:316–324. https://doi.org/10.1016/j.juro.2014.05.006
Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C (2015) Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol 67:750–763. https://doi.org/10.1016/j.eururo.2014.10.029
Gambaro G, Croppi E, Coe F, Lingeman J, Moe O, Worcester E, Buchholz N, Bushinsky D, Curhan GC, Ferraro PM, Fuster D, Goldfarb DS, Heilberg IP, Hess B, Lieske J, Marangella M, Milliner D, Preminger GM, Reis Santos JM, Sakhaee K, Sarica K, Siener R, Strazzullo P, Williams JC (2016) Consensus Conference, Metabolic diagnosis and medical prevention of calcium nephrolithiasis and its systemic manifestations: a consensus statement. J Nephrol 29:715–734. https://doi.org/10.1007/s40620-016-0329-y
Song S, Thomas I-C, Ganesan C, Sohlberg EM, Chertow GM, Liao JC, Conti S, Elliott CS, Pao AC, Leppert JT (2019) Twenty-four hour urine testing and prescriptions for urinary stone disease-related medications in veterans. Clin J Am Soc Nephrol 14:1773–1780. https://doi.org/10.2215/CJN.03580319
Qaseem A, Dallas P, Forciea MA, Starkey M, Denberg TD (2014) Clinical guidelines committee of the American college of, dietary and pharmacologic management to prevent recurrent nephrolithiasis in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med 161:659–667
Hsi RS, Yan PL, Crivelli JJ, Goldfarb DS, Shahinian V, Hollingsworth JM (2022) Comparison of selective vs empiric pharmacologic preventive therapy of kidney stone recurrence with high-risk features. Urology. https://doi.org/10.1016/j.urology.2021.12.037
Song S, Thomas I-C, Ganesan C, Velaer KN, Chertow GM, Pao AC, Leppert JT (2022) Twenty-four-hour urine testing and urinary stone disease recurrence in veterans. Urology 159:33–40. https://doi.org/10.1016/j.urology.2021.10.005
Samson PC, Holt SK, Hsi RS, Sorensen MD, Harper JD (2020) The Association between 24-hour urine and stone recurrence among high risk kidney stone formers: a population level assessment. Urology. https://doi.org/10.1016/j.urology.2020.05.064
Hsi RS, Yan PL, Goldfarb DS, Egbuji A, Si Y, Shahinian V, Hollingsworth JM (2021) Comparison of selective versus empiric pharmacologic preventative therapy with kidney stone recurrence. Urology. https://doi.org/10.1016/j.urology.2020.11.054
Goldfarb DS (2018) Empiric therapy for kidney stones. Urolithiasis. https://doi.org/10.1007/s00240-018-1090-6
Fink HA, Wilt TJ, Eidman KE, Garimella PS, MacDonald R, Rutks IR, Brasure M, Kane RL, Ouellette J, Monga M (2013) Medical management to prevent recurrent nephrolithiasis in adults: a systematic review for an American College of Physicians Clinical Guideline. Ann Intern Med 158:535–543. https://doi.org/10.7326/0003-4819-158-7-201304020-00005
Borghi L, Schianchi T, Meschi T, Guerra A, Allegri F, Maggiore U, Novarini A (2002) Comparison of two diets for the prevention of recurrent stones in idiopathic hypercalciuria. N Engl J Med 346:77–84. https://doi.org/10.1056/NEJMoa010369
Kocvara R, Plasgura P, Petrik A, Louzensky G, Bartonickova K, Dvoracek J (1999) A prospective study of nonmedical prophylaxis after a first kidney stone. BJU Int 84:393–398
Ferraro PM, Ticinesi A, Meschi T, Rodgers A, di Maio F, Fulignati P, Borghi L, Gambaro G (2018) Short-term changes in urinary relative supersaturation predict recurrence of kidney stones: a tool to guide preventive measures in urolithiasis. J Urol 200:1082–1087. https://doi.org/10.1016/j.juro.2018.06.029
Prochaska M, Taylor E, Ferraro PM, Curhan G (2018) Relative supersaturation of 24-hour urine and likelihood of kidney stones. J Urol 199:1262–1266. https://doi.org/10.1016/j.juro.2017.10.046
EDGE Research Consortium Annual Meeting, March 31, 2019. Cleveland, Ohio. https://www.endoedge.org/. Last accessed December 6, 2022.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377–381. https://doi.org/10.1016/J.JBI.2008.08.010
Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A (1996) Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study. J Urol 155:839–843
Shuster J, Jenkins A, Logan C, Barnett T, Riehle R, Zackson D, Wolfe H, Dale R, Daley M, Malik I, Schnarch S (1992) Soft drink consumption and urinary stone recurrence - a randomized prevention trial. J Clin Epidemiol 45:911–916. https://doi.org/10.1016/0895-4356(92)90074-W
Alexander RT, McArthur E, Jandoc R, Welk B, Fuster DG, Garg AX, Quinn RR (2018) Thiazide diuretic dose and risk of kidney stones in older adults: a retrospective cohort study. Can J Kidney Health Dis 5:2054358118787480. https://doi.org/10.1177/2054358118787480
Ceylan K, Topal C, Erkoc R, Sayarlioglu H, Can S, Yilmaz Y, Dogan E, Algun E, Gonulalan H (2005) Effect of indapamide on urinary calcium excretion in patients with and without urinary stone disease. Ann Pharmacother 39:1034–1038. https://doi.org/10.1345/aph.1E544
Borghi L, Meschi T, Guerra A, Novarini A (1993) Randomized prospective study of a nonthiazide diuretic, indapamide, in preventing calcium stone recurrences. J Cardiovasc Pharmacol 22(Suppl 6):S78-86
Penniston KL, Wertheim ML, Nakada SY, Jhagroo RA (2016) Factors associated with patient recall of individualized dietary recommendations for kidney stone prevention. Eur J Clin Nutr 70:1062–1067. https://doi.org/10.1038/EJCN.2016.79
Parks JH, Coward M, Coe FL (1997) Correspondence between stone composition and urine supersaturation in nephrolithiasis. Kidney Int 51:894–900
Conway JM, Ingwersen LA, Moshfegh AJ (2004) Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study. J Am Diet Assoc 104:595–603. https://doi.org/10.1016/j.jada.2004.01.007
Conway JM, Ingwersen LA, Vinyard BT, Moshfegh AJ (2003) Effectiveness of the US department of agriculture 5-step multiple-pass method in assessing food intake in obese and nonobese women. Am J Clin Nutr 77:1171–1178. https://doi.org/10.1093/AJCN/77.5.1171
Dauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS, Hollenbeck BK, Hollingsworth JM (2016) Medication Nonadherence and Effectiveness of Preventive Pharmacological Therapy for Kidney Stones. J Urol 195:648–652. https://doi.org/10.1016/j.juro.2015.10.082
Song Y, Hernandez N, Shoag J, Goldfarb DS, Eisner BH (2016) Potassium citrate decreases urine calcium excretion in patients with hypocitraturic calcium oxalate nephrolithiasis. Urolithiasis 44:145–148. https://doi.org/10.1007/s00240-015-0819-8
Whitson JM, Cooperberg MR, Stackhouse GB, Stoller ML (2007) Urinary citrate levels do not correlate with urinary pH in patients with urinary stone formation. Urology 70:634–637. https://doi.org/10.1016/j.urology.2007.04.052
Pak CYC, Maalouf NM, Rodgers K, Poindexter JR (2009) Comparison of semi-empirical and computer derived methods for estimating urinary saturation of calcium oxalate. J Urol 182:2951–2956. https://doi.org/10.1016/j.juro.2009.08.015
Moreira DM, Friedlander JI, Hartman C, Elsamra SE, Smith AD, Okeke Z (2013) Using 24-hour urinalysis to predict stone type. J Urol 190:2106–2111. https://doi.org/10.1016/j.juro.2013.05.115
Hartman C, Friedlander JI, Moreira DM, Leavitt DA, Hoenig DM, Smith AD, Okeke Z (2015) Does hypertension impact 24-hour urine parameters in patients with Nephrolithiasis? Urology 85:539–543. https://doi.org/10.1016/j.urology.2014.12.013
Sawyer MD, Dietrich MS, Pickens RB, Herrell SD, Miller NL (2013) Adequate or not? A comparison of 24-hour urine studies for renal stone prevention by creatinine to weight ratio. J Endourol 27:366–369. https://doi.org/10.1089/end.2012.0203
Moreira DM, Friedlander JI, Hartman C, Elsamra SE, Smith AD, Okeke Z (2013) Differences in 24-hour urine composition between apatite and brushite stone formers. Urology 82:768–772. https://doi.org/10.1016/j.urology.2013.04.025
Sui W, Calvert JK, Kavoussi NL, Gould ER, Miller NL, Bejan CA, Hsi RS (2020) Association of chronic kidney disease stage with 24-hour urine values among patients with Nephrolithiasis. J Endourol 34:1263–1271. https://doi.org/10.1089/end.2020.0403
Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel J-M, Sundararajan V (2011) Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol 173:676–682. https://doi.org/10.1093/aje/kwq433
ICMJE | Recommendations | Defining the Role of Authors and Contributors, (n.d.). https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html (accessed November 7, 2022).
Milose JC, Kaufman SR, Hollenbeck BK, Wolf JS, Hollingsworth JM (2014) Prevalence of 24-hour urine collection in high risk stone formers. J Urol 191:376–380. https://doi.org/10.1016/j.juro.2013.08.080
Hsi RS, Sanford T, Goldfarb DS, Stoller ML (2017) The role of the 24-hour urine collection in the prevention of kidney stone recurrence. J Urol. https://doi.org/10.1016/j.juro.2016.10.052
Pak CYC, Britton F, Peterson R, Ward D, Northcutt C, Breslau NA, Mcguire J, Sakhaee K, Bush S, Nicar M, Norman DA, Peters P (1980) Ambulatory evaluation of nephrolithiasis - classification, clinical presentation and diagnostic-criteria. Am J Med 69:19–30
Pak CY, Poindexter JR, Adams-Huet B, Pearle MS (2003) Predictive value of kidney stone composition in the detection of metabolic abnormalities. Am J Med 115:26–32
Curhan GC, Willett WC, Speizer FE, Stampfer MJ (2001) Twenty-four-hour urine chemistries and the risk of kidney stones among women and men. Kidney Int 59:2290–2298. https://doi.org/10.1046/j.1523-1755.2001.00746.x
Gentle DL, Stoller ML, Bruce JE, Leslie SW (1997) Geriatric urolithiasis. J Urol 158:2221–2224
Nayan M, Elkoushy MA, Andonian S (2012) Variations between two 24-hour urine collections in patients presenting to a tertiary stone clinic. Can Urol Assoc J 6:30–33. https://doi.org/10.5489/cuaj.11131
Parks JH, Goldfisher E, Asplin JR, Coe FL (2002) A single 24-hour urine collection is inadequate for the medical evaluation of nephrolithiasis. J Urol 167:1607–1612