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

项目总结 肾结石可引起剧烈疼痛，并与肾脏损伤、感染和肾质量下降有关。 生活。肾结石的患病率在所有人口群体中都有所上升，特别是在女性中， 儿童和少数族裔。所有肾结石患者都有发生未来症状事件的风险。因此， 确定适当的预防策略以防止未来的症状性事件将改善健康和 降低与泌尿系结石疾病相关的护理费用。 预防未来肾结石发作的饮食和药物干预是有效的，这些 由于肾结石疾病是一种慢性病，干预措施需要终生进行。这些干预措施可以 负担沉重，有副作用，并有相关的成本。临床指南小组在以下问题上存在分歧 临床医生应该进行选择性治疗：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。另一种策略是经验性治疗：在没有干预的情况下进行干预 24小时尿检。没有试验比较选择性药物干预策略和经验性药物干预策略 降低肾结石复发风险。相比之下，到目前为止比较这两种策略的饮食研究已经 方法论缺陷限制了他们的解释。 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。主要结果将是草酸钙和钙的平均计算过饱和度。 磷酸盐。Aim 1将进行一项随机临床试验，比较选择性与经验性饮食和药物治疗 治疗疑似特发性钙结石的患者经验组将有预先分配的饮食 推荐和每日服用噻嗪加柠檬酸钾，而选择性组将开出 24小时尿检指导下的个体化饮食和用药方案。次要结果将是 评估与干预相关的其他尿液参数和不良事件。AIM 2将评估不利 选择性和经验性策略的影响，并评估患者的依从性。建议项目的贡献 预计研究将确定什么预防策略在肾结石患者中效果最好， 都有肾结石复发的风险。

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.