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：
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
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/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

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.

项目概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。所有人口群体的肾结石患病率均有所上升，尤其是女性，儿童和少数民族。所有肾结石患者未来都有出现症状事件的风险。所以，确定适当的预防策略来预防未来的症状事件将改善健康和减少泌尿系结石疾病的护理相关费用。饮食和药物干预对于预防未来肾结石发作是有效的，这些由于肾结石病是一种慢性疾病，因此需要终生进行干预。干预措施可以是繁重的，有副作用，并且有相关的成本。临床指南小组对于是否临床医生应进行选择性治疗：进行 24 小时尿液检测，以指导选择干预措施纠正异常的泌尿参数。另一种策略是经验疗法：在不干预的情况下进行干预 24小时尿液检测。没有试验将选择性药物干预策略与经验性药物干预策略进行比较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已经表明方法上的缺陷限制了他们的解释。我们的总体目标是比较选择性策略和经验策略治疗肾结石的有效性和安全性预防。主要结果是草酸钙和钙的平均计算过饱和度磷酸盐。目标 1 将进行选择性饮食与经验性饮食和药理学的随机临床试验治疗疑似特发性钙结石的患者经验组将接受预先指定的饮食建议每天服用噻嗪类药物和柠檬酸钾，而选择性组将服用以 24 小时尿液检测为指导的个体化饮食和药物治疗方案。次要结果将评估与干预措施相关的其他泌尿参数和不良事件。目标 2 将评估不良情况选择性和经验性策略的影响并评估患者的依从性。拟议的贡献预计研究将确定哪些预防策略对肾结石患者最有效，这些患者所有人都有肾结石复发的风险。