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

肾结石的经验性预防策略与选择性预防策略的随机试验

基本信息

批准号：
10426435
负责人：
RYAN HSI
金额：
$ 34.98万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-05-15 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10426435
关键词：
Acute Renal Failure with Renal Papillary Necrosis Address Adherence Adverse effects Adverse event American College of Physicians Calcium Calcium Oxalate Caring Child Chronic Clinical Complex Conflict (Psychology)Data Diet Disease Event Flank Pain Foundations Future Goals Guidelines Health Healthcare High Prevalence Hour Incidence Infection Injury to Kidney Insurance Carriers Intervention Kidney Calculi Knowledge Longitudinal prospective study Methodology Minority Nature Nephrology Outcome Pain Participant Patient Recruitments Patients Pharmaceutical Preparations Pharmacology Placebos Population Prevalence Prevention Prevention strategy Preventive treatment Publishing Quality of life Randomized Randomized Clinical Trials Recommendation Recurrence Regimen Research Risk Safety Symptoms Test Result Testing Urinary Calculi Urine Urology Vision Woman Work base calcium phosphate care costs comparative effectiveness compare effectiveness compliance behavior cost follow-up high risk improved medical specialties potassium citrate prevent preventive intervention primary outcome randomized trial recruit secondary outcome side effect standard of care thiazide urinary

项目摘要

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.

项目总结