A Randomized Clinical Trial to Evaluate the Effectiveness of Oral Potassium Citrate in Preventing… (NCT06819553) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Randomized Clinical Trial to Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones
Egypt48 participantsStarted 2024-11-03
Plain-language summary
This randomized clinical trial aims to evaluate the efficacy of oral potassium citrate in reducing ureteral stent encrustation following ureteroscopy for uric acid kidney stones. The study will assess whether potassium citrate, by raising urinary pH, can prevent encrustation on stents, potentially improving patient outcomes and reducing complications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Participants must meet all of the following criteria to be eligible)
* Age: ≥18 years old.
* Diagnosis: Patients undergoing ureteral stenting post-ureteroscopy for uric acid kidney stones.
* Urinary pH: ≤5.5 at baseline (acidic urine).
* Willingness to Participate: Patients who provide informed consent to participate in the study.
Exclusion Criteria (Participants will be excluded if they meet any of the following criteria) Renal Function: Patients with significantly impaired kidney function (elevated creatinine beyond normal limits).
Infections: History of febrile urinary tract infection (UTI) at the time of enrollment.
Metabolic Disorders:
Chronic kidney disease (CKD) Stage 3 or higher. History of hyperkalemia. Pregnancy: Pregnant or breastfeeding women. Residual Stones: Patients with residual stone burden after ureteroscopy that may confound outcomes.
Medication Interference: Patients on medications that significantly alter urinary pH (e.g., sodium bicarbonate, acetazolamide) or those contraindicated with potassium citrate.
Other Severe Comorbidities: Any condition that, in the investigator's judgment, would interfere with study participation or pose excessive risk.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the rate of encrustation on the ureteral stents, which will be assessed after stent removal using a modified scoring system.
Timeframe: Stent removal, typically 4-6 weeks after ureteroscopy.