Randomized Intervention for Vesico-Ureteral Reflux (RIV*

膀胱输尿管反流的随机干预 (RIV*

• 批准号: 7035584
• 负责人: RANJIV I MATHEWS
• 金额: $ 39.98万
• 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/7035584
• 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)是尿路感染(UTI)儿童常见的症状。VUR与严重情况有关，包括急性肾盂肾炎和永久性肾脏损伤，导致瘢痕形成、肾损害(“反流性肾病”)和终末期肾脏疾病。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广泛应用于儿童输尿管返流的治疗，但在前瞻性随机试验中，这两种方法都没有显示出优于监测的结果，而且两者都可能存在重大风险。这项拟议的研究将在一项前瞻性的随机试验中，通过比较不干预(监测)、预防性抗生素和手术矫正(内窥镜注射膨胀剂)来确定诊断为输尿管返流的儿童的最佳初始治疗方法。在一个由五个临床治疗中心和一个数据中心组成的多中心协作中，我们将在两年内招募600名VUR患者(年龄在10岁或以下)，并对他们进行2.5-4.5年的跟踪。这项研究将确定尿路感染、反流性肾病和其他结果的发生率的差异。布雷迪泌尿研究所和约翰·霍普金斯医院的儿科肾病科是唯一适合实施这项拟议研究的机构，拥有一支综合的多学科研究团队，在多中心临床研究的设计和实施方面拥有丰富的经验，并拥有大量的临床病例和治疗VUR儿童的经验。VUR目前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极大地改变临床实践，因为它为VUR儿童的最佳初始治疗提供了明确的证据。 儿童尿路感染每年就诊100多万次，住院30,000-40,000次。这些儿童中的许多人都有膀胱输尿管返流(一种尿液不适当地从膀胱回流到肾脏的情况)，这可能会使这些儿童容易发生尿路感染。虽然膀胱输尿管再流可以通过手术矫正，但目前还不清楚这是否有益；这项研究将对膀胱输尿管返流的几种治疗方法进行比较，以确定哪种治疗方法最好。