Clinical trial NCT04727606: Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence
Official title: Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Kidney Stone
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In clinical practice, many patients are not able to modify their habits to achieve a high level of diuresis and fluid intake and therefore are at an elevated risk for stone recurrence.

The investigators think that Ure-Na (osmotic agent) taking could help to increase urine volume and decrease urine concentration, which would be of benefit in the prevention of kidney stones.


Eligibility criteria: Inclusion Criteria:

* 18 to 60 years of age
* High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.)
* Diuresis \< 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months)

Exclusion Criteria:

* Patient does not meet 1 of the 3 inclusion criteria
* Pregnancy or breastfeeding
* Lack of understanding about the protocol and effects of Ure-Na
* Expected inability to adequately increase fluid intake on Ure-Na

Primary outcomes:
measure: Change From Baseline in urine output at 1 week and 1 Month
timeFrame: 1 week and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
References:
citation: Dion M, Ankawi G, Chew B, Paterson R, Sultan N, Hoddinott P, Razvi H. CUA guideline on the evaluation and medical management of the kidney stone patient - 2016 update. Can Urol Assoc J. 2016 Nov-Dec;10(11-12):E347-E358. doi: 10.5489/cuaj.4218. Epub 2016 Nov 10. No abstract available.
citation: Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A. Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study. J Urol. 1996 Mar;155(3):839-43.
citation: Soupart A, Coffernils M, Couturier B, Gankam-Kengne F, Decaux G. Efficacy and tolerance of urea compared with vaptans for long-term treatment of patients with SIADH. Clin J Am Soc Nephrol. 2012 May;7(5):742-7. doi: 10.2215/CJN.06990711. Epub 2012 Mar 8.
citation: Berl T. Impact of solute intake on urine flow and water excretion. J Am Soc Nephrol. 2008 Jun;19(6):1076-8. doi: 10.1681/ASN.2007091042. Epub 2008 Mar 12.
citation: Decaux G, Brimioulle S, Genette F, Mockel J. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone by urea. Am J Med. 1980 Jul;69(1):99-106. doi: 10.1016/0002-9343(80)90506-9.
citation: Verbalis JG, Baldwin EF, Neish PN, Robinson AG. Effect of protein intake and urea on sodium excretion during inappropriate antidiuresis in rats. Metabolism. 1988 Jan;37(1):46-54. doi: 10.1016/0026-0495(88)90028-5.
citation: Nayan M, Elkoushy MA, Andonian S. Variations between two 24-hour urine collections in patients presenting to a tertiary stone clinic. Can Urol Assoc J. 2012 Feb;6(1):30-3. doi: 10.5489/cuaj.11131.