跳至主要内容
临床试验/NCT03270540
NCT03270540已完成不适用

Abdominal Ultrasonography in Urinary Tract Infection - When and Why?

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
USG abnormality persistence

研究概览

简要总结

Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in children with first episode of UTI.

Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children with UTI. Abnormalities suggesting CAKUT found on USG are an indication for further, more invasive tests. The timing of USG in UTI depends on the clinical situation. It always should be performed urgently when serious acute complications of UTI are suspected. However, appropriate timing of USG in children responding well to therapy, is a matter of debate. According to animal studies, E. coli produces toxin which dilates the urinary tract. This may result in misleading picture on USG in acute phase of infection. Guidelines on UTI management in children differ in respect to recommended USG timing.

The purpose of the study is to investigate how UTI does affect USG results in children and when its effect subsides.

Methods 150 children up to 3 years of age, with the first episode of UTI, will be included in our study. Three USG examinations will be performed by single radiologist in every child:

  1. in the first day of treatment,
  2. two weeks after treatment initiation,
  3. four weeks after treatment initiation. Age, gender, etiologic factor, C-reactive protein concentration and white blood cells count will be included in statistical analysis.

The study is aimed to help clinicians interpret USG findings during UTI and make reasonable plans for further imaging diagnostics in children with UTI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • laboratory diagnosis of UTI in a child (positive leucocyturia and significant bacteriuria)

排除标准

  • known previous UTIs
  • known congenital abnormality of the kidney and the urinary tract (CAKUT)

结局指标

主要结局

USG abnormality persistence

时间窗: 4 weeks

significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magdalena Okarska-Napierała

MD

Medical University of Warsaw

研究点 (1)

Loading locations...

相似试验