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.

项目摘要肾结石会引起严重的疼痛，并与肾脏损伤，感染和降低的质量有关生活。肾结石疾病的患病率在所有人口组中，尤其是在女性中，儿童和少数民族。所有肾结石患者都有发生未来症状事件的风险。所以，确定适当的预防策略以防止未来的症状事件，将改善健康状况降低与护理相关的尿道疾病的成本。防止将来的肾结石发作的饮食和药理学干预措施有效，这些由于肾结石病是慢性病，因此一生中进行了干预措施。干预措施可以负担沉重，有副作用并有相关的成本。临床指南面板不同意是否存在临床医生应进行选择性治疗：进行24小时尿液测试以指导选择干预措施正确的异常尿参数。替代策略是经验疗法：应用干预措施 24小时尿液测试。没有试验将选择性与经验药理学干预策略进行比较降低肾结石复发风险。相比之下，迄今为止的饮食研究与这两种策略进行了比较方法论缺陷限制了它们的解释。我们的总体目标是比较肾结石的选择性和经验策略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。 AIM 1将对选择性与经验性饮食和药理学的随机临床试验对假定特发性钙结石的治疗患者经验组将预先分配饮食建议和每天用柠檬酸钾的噻嗪类在24小时尿液测试的指导下，个性化饮食和药物治疗方案。次要结果将评估与干预措施有关的其他尿参数和不良事件。 AIM 2将评估不利选择性和经验策略的影响并评估患者的依从性。提议的贡献预计研究将确定哪些预防策略在肾结石患者中最有效都有肾结石复发的风险。