Actively Recruiting
Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-11-10
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two medical treatment approaches to prevent calcium oxalate kidney stones in patients undergoing percutaneous nephrolithotomy (PCNL) at a single center. This randomized controlled trial aims to compare empiric therapy, based on stone composition and urinalysis, to selective therapy guided by 24-hour urine metabolic evaluation. The primary goal is to see if a simpler empiric method can achieve similar outcomes as the more detailed selective therapy by measuring changes in calcium oxalate supersaturation four weeks after treatment. Participants will be randomly assigned after surgery to either the empiric or selective therapy groups. The empiric group receives treatment based on stone type: low oxalate diet counseling for calcium oxalate monohydrate stone formers, chlorthalidone 25 mg daily for calcium oxalate dihydrate stone formers, or both if stones contain equal parts of each type. The selective group receives therapy guided by 24-hour urine results, following American Urological Association guidelines, with diet or chlorthalidone prescribed based on specific urine findings such as hyperoxaluria or hypercalciuria. During the study, participants will be monitored for changes in calcium oxalate supersaturation at 4 to 6 weeks post-treatment. Additional assessments include urinary oxalate and calcium levels and adherence to chlorthalidone therapy using a questionnaire. The study involves medical evaluations, dietary counseling, and medication monitoring to understand which approach best prevents recurrent stones, with a total participation timeframe covering treatment and follow-up over several weeks.
CONDITIONS
Brief Title
CaOx Stone Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult age of 18 years
- Diagnosed with kidney stones and scheduled for percutaneous nephrolithotomy (PCNL)
- Calcium oxalate stone former
- Pre-operative CT scan within 90 days of surgery with stone density greater than 1000 Hounsfield units
- Non-pregnant and not breastfeeding
- Able and willing to provide informed consent
- Pre-operative estimated glomerular filtration rate (eGFR) greater than 70 mL/min/1.73 m²
- Negative pre-operative urine culture
You will not qualify if you...
- History of gastric or intestinal bypass surgery, liver disease, or gastrointestinal malabsorptive diseases such as Crohn's disease, ulcerative colitis, or short-gut syndrome
- Hyperparathyroidism or renal tubular acidosis
- Active kidney stone prevention treatment at surgery (including use of thiazides, alkaline therapy, or low oxalate diet)
- History of hypokalemia or baseline low blood pressure (hypotension)
- Allergy to medications used in the trial or sulfa-containing medications
- Current prescription of thiazide, loop diuretics, carbonic anhydrase inhibitors, xanthine oxidase inhibitors, active Vitamin D, bisphosphonates, denosumab, glucocorticoids, or potassium supplements
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to surgery
Duration - 1 to 2 days
Participants undergo percutaneous nephrolithotomy (PCNL) surgery to remove calcium oxalate kidney stones and receive immediate post-operative care.
Hospital stay for surgery and recovery
Duration - 4 to 6 weeks
Participants receive either empiric or selective medical therapy based on stone composition or 24-hour urine metabolic evaluation to prevent calcium oxalate stone recurrence. This includes taking chlorthalidone and/or following a low oxalate diet as prescribed.
1 baseline visit post-surgery and weekly visits for up to 4 to 6 weeks
Duration - Up to 1 week after treatment
Participants complete assessments including urine tests and adherence surveys to evaluate the effectiveness of the prevention therapies.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
Research Team
B
Blair Gallante, MPH
M
Mantu Gupta, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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