Randomized Intervention for Vesico-Ureteral Reflux (RIV*

膀胱输尿管反流的随机干预 (RIV*

• 批准号: 7127268
• 负责人: RANJIV I MATHEWS
• 金额: $ 8.33万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7127268
• 关键词: antiinfective agents; biomaterials; chemoprevention; child (0-11); clinical research; clinical trials; cooperative study; disease /disorder prevention /control; human subject; human therapy evaluation; injury; kidney disorder; longitudinal human study; patient oriented research; pediatric pharmacology; pediatrics; relapse /recurrence; scars; urinary bladder disorder; urinary tract imaging /visualization; urinary tract infection; urinary tract surgery

DESCRIPTION (provided by applicant): Vesico-ureteral reflux (VUR) is a common condition seen among children with urinary tract infection (UTI). VUR is associated with serious conditions including acute pyelonephritis and permanent renal injury, leading to scarring, renal impairment ("reflux nephropathy") and end-stage renal disease. However, the optimal treatment for VUR remains unclear. Both prophylactic antibiotics and surgical correction have been widely implemented for management of children with VUR, but neither of these has been shown in prospective randomized trials to be superior in outcomes to surveillance, and both may have significant risks. The proposed research will identify the optimal initial management approach for children diagnosed with VUR, by comparing non-intervention (surveillance), prophylactic antibiotics, and surgical correction (endoscopic injection of bulking agent) in a prospective, randomized trial. In a multi-center collaboration of five clinical treatment centers and one data center, over 2 years we will enroll 600 patients with VUR (ages 10 years or less), and follow them for 2.5-4.5 years. This study will identify differences in incidence of UTI, reflux nephropathy, and other outcomes. The Brady Urological Institute and the Division of Pediatric Nephrology at Johns Hopkins Hospital are uniquely suited to the execution of the proposed research, with an integrated multi-disciplinary research team, extensive experience in the design and execution of multi-center clinical research, and substantive clinical caseload and experience in treatment of children with VUR. Much of the current management of VUR is based on case series and anecdotes. The information gained from this research has the potential to dramatically change clinical practice, by providing definitive evidence of the optimal initial management of children with VUR. Urinary tract infections in children account for over a million doctor visits per year, and 30,000-40,000 hospitalizations per year. Many of these children have vesico-ureteral reflux (a condition where urine improperly flows backwards out of the bladder toward the kidney), and this may predispose these children to urinary infections. While vesico-ureteral relux [sic] can be corrected surgically, it is unclear whether this is beneficial; this research study will compare several management approaches to vesicoureteral reflux to determine which is best

描述（由申请人提供）： 膀胱输尿管反流（VUR）是儿童尿路感染（UTI）的常见疾病。VUR与包括急性肾盂肾炎和永久性肾损伤在内的严重疾病相关，导致瘢痕形成、肾损害（“反流性肾病”）和终末期肾病。然而，VUR的最佳治疗方法仍不清楚。预防性抗生素和手术矫正已被广泛应用于VUR儿童的管理，但在前瞻性随机试验中，这两种方法在结局上均未显示出优于监测的上级效果，而且两者都可能具有显著的风险。拟议的研究将通过在一项前瞻性随机试验中比较非干预（监测）、预防性抗生素和手术矫正（内镜下注射膨胀剂），确定诊断为VUR的儿童的最佳初始管理方法。在五个临床治疗中心和一个数据中心的多中心合作中，我们将在2年内招募600名VUR患者（年龄10岁或以下），并对他们进行2.5-4.5年的随访。本研究将确定UTI、反流性肾病和其他结局发生率的差异。布雷迪泌尿外科研究所和约翰霍普金斯医院的儿科肾病科是唯一适合执行拟议研究的机构，拥有一个综合的多学科研究团队，在多中心临床研究的设计和执行方面拥有丰富的经验，以及大量的临床病例和治疗VUR儿童的经验。目前对VUR的大部分管理都是基于案例系列和轶事。从这项研究中获得的信息有可能大大改变临床实践，通过提供明确的证据，最佳的初始管理儿童VUR。 儿童尿路感染每年导致100多万人次就医，30，000 - 40，000人次住院。这些儿童中的许多人有膀胱输尿管反流（尿液不正常地从膀胱向肾脏回流的情况），这可能使这些儿童容易患尿路感染。虽然膀胱输尿管反流[原文如此]可以通过手术纠正，但尚不清楚这是否有益;这项研究将比较膀胱输尿管反流的几种管理方法，以确定哪一种是最好的