Optimizing Fluid Therapy and Stent Management in Children and Adults with Nephrolithiasis

优化患有肾结石的儿童和成人的液体治疗和支架管理

• 批准号: 9334857
• 负责人: NAIM M MAALOUF
• 金额: $ 72.31万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9334857
• 关键词: Absenteeism; Achievement; Address; Adherence; Adrenergic alpha-Antagonists; Adult; American; American College of Physicians; Analgesics; Biocompatible Materials; Biological Factors; Blood; Calcium; Caring; Child; Childhood; Chronic Kidney Failure; Clinical Trials; Cohort Studies; Color; Counseling; Custom; DNA; Data; Development; Disease; Disease Progression; Effectiveness; Enrollment; European; Feces; Feedback; Fluid Therapy; Frequencies; Glucocorticoids; Goals; Growth; Guidelines; Habits; Health; Hematuria; Inflammation; Institution; Intake; Intervention; Kidney; Knowledge; Lead; Life Style; Liquid substance; Measures; Methylprednisolone; Modification; Monitor; Morbidity - disease rate; Nephrolithiasis; Non-Malignant; Obstruction; Oral; Pain; Participant; Pathogenicity; Pathology; Pathway interactions; Patient Care; Patient risk; Patients; Periodicity; Perioperative complication; Pharmaceutical Preparations; Pharmacology; Placebos; Prevalence; Prevention; Procedures; Protocols documentation; Psychometrics; Public Health; Quality of life; Randomized; Recruitment Activity; Recurrence; Registries; Research; Research Infrastructure; Research Personnel; Resource Sharing; Resources; Safety; Sampling; Societies; Specific Gravity; Specimen; Stents; Symptoms; Testing; Thinness; Time; Treatment Efficacy; Tube; Ureter; Ureteroscopy; Urinary Calculi; Urinary tract infection; Urine; base; biobank; cost; high risk; improved; mobile application; mobile computing; multidisciplinary; pediatric patients; prevent; reduce symptoms; standard care; standard of care; therapeutic evaluation; urologic; young man

Project Summary: Urinary Stone Disease (USD) is an increasingly prevalent and highly recurrent condition associated with major morbidity at a rising cost to society. Thus, improved management can significantly reduce its health burden. Increasing fluid intake is recommended to all USD patients. However, knowledge gaps persist regarding the impact of fluid therapy in preventing USD recurrence including the optimal urine volume, safety of fluid therapy, effectiveness of strategies to achieve and maintain a high urine volume, and whether such strategies reduce USD recurrence. Although ureteral stenting is routinely performed after urological procedures for USD to mitigate peri-operative complications, stents cause significant patient discomfort. The causal mechanisms are only partly understood, and use of new stent biomaterial and medications post-stenting only partly relieve these symptoms. Limiting inflammation is one pathway to reduce stent-related discomfort. Based on current knowledge, we submit the following hypotheses: 1. Compared to standard practice, a strategy achieving a higher urine volume by combining counseling, frequent reminders, and fluid intake modification by feedback, safely reduces USD recurrence. 2. Biological factors identify USD patients likely to develop stent-related symptoms, and oral glucocorticoids reduce stent-related discomfort by mitigating inflammation. To test these hypotheses, we will pursue the following objectives in a multi-center collaborative effort: Aim 1. We will compare USD progression in patients randomized to standard care vs. achievement of a urine volume >2.5 L/day in adult and >30 ml/Kg/day in pediatric USD patients. We will also assess the impact of a customized strategy [combining counseling, frequent reminders (via mobile technology), and modification of fluid intake habits using feedback (from periodic assessment of urine volume surrogates)] on preventing USD recurrence. Aim 2. We will evaluate USD patients undergoing ureteral stent insertion at the time of unilateral ureteroscopy for USD and receiving standard-of-care medications with pre-, and post-procedural psychometric testing to identify predictors of greater stent-related symptoms. Based on the findings, we will randomize high risk patients to a 5-day methylprednisolone course or matching placebo to determine whether methylprednisolone as an adjunctive therapy safely reduces stent- related symptoms. Aim 3. We will collect blood, urine, DNA and stool from stone formers as a resource for USD Research Network investigators and other researchers. To achieve these aims, this application will combine the expertise of established USD researchers and clinicians with a large base of USD patients to participate in a collaborative effort with other USD investigators with the ultimate aim of improving USD patient care.

项目概要： 泌尿系结石病（USD）是一种日益普遍和高度复发的疾病，与主要的泌尿系疾病有关。 社会成本不断上升。因此，改善管理可以大大减轻其健康负担。 建议所有USD患者增加液体摄入量。然而，在以下方面仍然存在知识差距： 液体治疗对预防USD复发的影响，包括最佳尿量，液体治疗的安全性， 策略的有效性，以实现和维持高尿量，以及这些策略是否减少 美元复发。尽管输尿管支架植入术是泌尿外科手术后的常规手术， 围手术期并发症，支架引起显著的患者不适。因果机制只是部分地 但是，新支架生物材料和支架植入后药物的使用只能部分缓解这些症状。 限制炎症是减少支架相关不适的一种途径。根据目前的知识，我们认为 以下假设：1.与标准实践相比，通过以下方式实现更高尿量的策略 结合咨询，经常提醒，并通过反馈调整液体摄入量，安全地减少USD 复发2.生物学因素确定了可能出现支架相关症状的USD患者， 糖皮质激素通过减轻炎症来减少支架相关的不适。为了验证这些假设，我们将 在多中心合作努力中追求以下目标：目标1。我们将比较美元的进展， 随机分配至标准治疗组的患者与成人尿量>2.5 L/天和>30 ml/Kg/天的患者 儿童USD患者。我们还将评估定制策略的影响[结合咨询， 频繁提醒（通过移动的技术），并使用反馈（从定期 尿量替代物的评估）]预防USD复发。目标2.我们将评估USD患者 在单侧输尿管镜检查治疗USD时接受输尿管支架植入并接受标准治疗 术前和术后心理测量测试的药物，以确定更大支架相关性的预测因素 症状根据研究结果，我们将高危患者随机分为5天甲基强的松龙疗程或 匹配的安慰剂，以确定甲基强的松龙作为连续治疗是否安全地减少支架植入， 相关症状。目标3。我们将收集结石患者的血液、尿液、DNA和粪便，作为美元的资源。 研究网络调查员和其他研究人员。为了实现这些目标，本申请将联合收割机 建立了USD研究人员和临床医生的专业知识，拥有大量的USD患者， 与其他USD研究人员合作，最终目的是改善USD患者护理。