This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones. Participants will be randomized to receive either empiric therapy or selective therapy guided by 24-hour urine evaluation. The primary outcome is change in calcium oxalate supersaturation at 4 weeks, aiming to determine whether empiric therapy can provide outcomes comparable to selective therapy while simplifying access to prevention.
This is a single-center, randomized controlled trial evaluating the effectiveness of empiric versus selective medical therapy for the prevention of calcium oxalate kidney stones. The study will enroll 80 patients at Mount Sinai West undergoing percutaneous nephrolithotomy (PCNL) for predominantly calcium oxalate stones. Participants will be randomized postoperatively to receive either empiric therapy (based on stone composition and urinalysis) or selective therapy (based on 24-hour urine metabolic evaluation). The primary endpoint is the change in calcium oxalate supersaturation (ssCaOx) at 4 weeks post-treatment. The study is designed to determine whether an empiric approach can achieve comparable outcomes to selective therapy while simplifying access to preventive treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Chlorthalidone 25 mg orally once daily is used to reduce urinary calcium excretion and prevent recurrent calcium-containing kidney stones. In this study, it is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants meeting criteria for hypercalciuria or calcium oxalate dihydrate stones.
Participants receive counseling to follow a low oxalate diet, limiting high oxalate foods (\>50 mg/100 g) and restricting moderate oxalate foods (\<50 mg/100 g) to a single four-ounce serving per day. The diet is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants with idiopathic hyperoxaluria or calcium oxalate monohydrate stones.
Mount Sinai West
New York, New York, United States
RECRUITINGChanges in super saturation of calcium oxalate
Change in urine calcium oxalate supersaturation from baseline to the final follow-up visit, measured via 24-hour urine collection. This is a marker that can be predictive of stone episodes, as recurrent stones may take years to develop.
Time frame: 4-6 weeks
Changes in urinary oxalate levels
Difference in 24-hour urinary oxalate excretion from baseline to the final follow-up visit, measured in mg/day, to assess the effect of dietary and pharmacologic interventions on oxalate levels.
Time frame: 4-6 weeks
Changes in urinary calcium levels
Difference in 24-hour urinary calcium excretion from baseline to the final follow-up visit, measured in mg/day, to evaluate the effect of chlorthalidone and dietary interventions on urinary calcium levels.
Time frame: 4-6 weeks
Chlorthalidone Adherence Survey (adapted from Brief Medication Questionnaire)
Participant-reported adherence to prescribed chlorthalidone therapy, assessed via a structured survey at the follow-up visit, to evaluate compliance with the study intervention. Response will be either 0=nonadherent or 1=adherent.
Time frame: 4-6 weeks
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