Vanderbilt University Medical Center
Ryan Hsi
The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.
Kidney Stones
Nephrolithiasis
Empiric Therapy: Diet
Empiric Therapy: Drug
Selective Therapy: Diet
Selective Therapy: Drug
Phase 4
Diet and pharmacologic interventions for preventing future kidney stone episodes are effective, however clinical guideline panels disagree on whether clinicians should perform selective therapy: performing 24-hour urine testing to guide choosing interventions to correct abnormal urinary parameters. The alternative strategy is empiric therapy: applying interventions without 24-hour urine testing. While 24-hour urine testing is considered the standard of care by nephrology and urology specialties for higher risk patients, the American College of Physicians does not recommend 24-hour urine testing. This is a randomized clinical trial of selective versus empiric therapy for patients with presumed idiopathic calcium stone disease, representing >80% of the kidney stone population. The primary outcome is change in urinary supersaturation, which associates with symptomatic stone recurrence. We will recruit patients with presumed idiopathic calcium stone disease with at least 2 stone events within the previous 5 years. Participants will be randomly assigned to empiric diet plus thiazide with potassium citrate daily, or to selective diet plus pharmacologic therapy based on the 24-hour urine abnormalities identified at baseline and adjusted during follow-up. The primary outcomes will be the calculated calcium oxalate and calcium phosphate supersaturations. In addition, we will determine adverse effects from, and adherence to, selective and empiric strategies.}}
Study Type : | Interventional |
Estimated Enrollment : | 56 participants |
Masking : | Quadruple |
Primary Purpose : | Prevention |
Official Title : | Randomized Trial of Empiric Versus Selective Prevention Strategies for Kidney Stone Disease |
Actual Study Start Date : | August 4, 2022 |
Estimated Primary Completion Date : | March 31, 2025 |
Estimated Study Completion Date : | March 31, 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Empiric Therapy Diet intervention and drug intervention not based on 24 hour urine results |
Behavioral: Empiric Therapy: Diet Drug: Empiric Therapy: Drug |
Experimental: Selective Therapy Diet intervention and drug intervention based on 24 hour urine results |
Behavioral: Selective Therapy: Diet Drug: Selective Therapy: Drug |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232