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

• 批准号: 10616785
• 负责人: RYAN HSI
• 金额: $ 34.76万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 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/10616785
• 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; Confusion; Data; Diet; Disease; Event; Flank Pain; Future; Goals; Guidelines; Health; Healthcare; High Prevalence; Hour; Incidence; Infection; Injury to Kidney; Insurance Carriers; Intervention; Kidney Calculi; Knowledge; Methodology; Minority; Nature; Nephrology; Outcome; Pain; Participant; Patient Recruitments; Patients; Pharmaceutical Preparations; Placebos; Population; Prevalence; Prevention; Prevention strategy; Preventive treatment; Publishing; Quality of life; Randomized; Recommendation; Recurrence; Regimen; Research; Risk; Safety; Symptoms; Test Result; Testing; Urinary Calculi; Urine; Urology; Woman; Work; calcium phosphate; care costs; comparative effectiveness; compare effectiveness; compliance behavior; cost; follow-up; high risk; improved; longitudinal, prospective study; medical specialties; pharmacologic; potassium citrate; prevent; preventive intervention; primary outcome; randomized trial; randomized, clinical trials; recruit; secondary outcome; side effect; standard of care; thiazide; urinary

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.

项目摘要 肾结石可引起剧烈疼痛，并与肾损伤、感染和肾功能下降有关。 生活肾结石疾病的患病率在所有人口群体中都有所上升，特别是在妇女中， 儿童和少数民族。所有肾结石患者都有发生未来症状性事件的风险。因此，我们认为， 确定适当的预防策略以预防未来的症状性事件将改善健康， 降低泌尿系结石疾病的护理费用。 预防未来肾结石发作的饮食和药物干预是有效的， 由于肾结石是一种慢性疾病，因此需要终生进行干预。干预措施可以 负担沉重，有副作用，并有相关的成本。临床指南小组不同意是否 临床医生应进行选择性治疗：进行24小时尿检，以指导选择干预措施， 纠正异常的尿液参数。另一种策略是经验疗法：应用干预措施， 24-小时尿检。没有试验比较选择性与经验性药物干预策略， 降低肾结石复发风险。相比之下，迄今为止比较这两种策略的饮食研究表明， 方法上的缺陷限制了它们的解释。 我们的总体目标是比较选择性和经验性治疗肾结石的有效性和安全性 预防主要结果将是平均计算的草酸钙和钙的过饱和度 磷酸盐目的1将进行一项选择性与经验性饮食和药理学的随机临床试验， 治疗假定的特发性钙结石患者经验组将有预先指定的饮食 建议和每日噻嗪与柠檬酸钾，而选择性组将规定， 根据24小时尿检指导个体化饮食和药物治疗方案。次要结局将 评估与干预相关的其他尿液参数和不良事件。目标2将评价不良反应 从选择性和经验性策略的影响，并评估患者的依从性。提议的捐助 预计研究将确定哪些预防策略对肾结石患者最有效， 都有肾结石复发的风险