# Randomized Trial of Empiric Versus Selective Preventative Strategies for Kidney Stone Disease

> **NIH NIH R01** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2022 · $349,814

## Abstract

PROJECT SUMMARY
Kidney stones can cause severe pain and are associated with kidney injury, infections, and reduced quality of
life. The prevalence of kidney stone disease has risen across all demographic groups, especially among women,
children, and minorities. All kidney stone patients are at risk for future symptomatic events. Therefore,
determining the appropriate preventative strategies to prevent future symptomatic events will improve health and
reduce the care-related costs for urinary stone disease.
Diet and pharmacologic interventions for preventing future kidney stone episodes are effective, and these
interventions are made over a lifetime due to kidney stone disease as a chronic condition. The interventions can
be burdensome, have side effects, and have associated costs. 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. No trials have compared selective versus empiric pharmacologic intervention strategies to
reduce kidney stone recurrence risk. In contrast, diet studies to date comparing these two strategies have had
methodologic flaws limiting their interpretation.
Our overall goal is to compare the effectiveness and safety of selective and empiric strategies for kidney stone
prevention. The primary outcomes will be mean calculated supersaturations of calcium oxalate and calcium
phosphate. Aim 1 will perform a randomized clinical trial of selective versus empiric diet and pharmacologic on
therapy patients with presumed idiopathic calcium stones The empiric group will have pre-assigned diet
recommendations and daily thiazide with potassium citrate, whereas the selective group will be prescribed an
individualized diet and medication regimen as guided by 24-hour urine testing. Secondary outcomes will
evaluate other urinary parameters and adverse events related to the interventions. Aim 2 will evaluate adverse
effects from selective and empiric strategies and assess patient adherence. The contribution of the proposed
research is expected to be identifying what preventative strategies work best among kidney stone patients, who
are all at risk for kidney stone recurrence.

## Key facts

- **NIH application ID:** 10426435
- **Project number:** 1R01DK129202-01A1
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** RYAN HSI
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $349,814
- **Award type:** 1
- **Project period:** 2022-05-15 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10426435

## Citation

> US National Institutes of Health, RePORTER application 10426435, Randomized Trial of Empiric Versus Selective Preventative Strategies for Kidney Stone Disease (1R01DK129202-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10426435. Licensed CC0.

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