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临床试验/NCT04055675
NCT04055675已完成不适用

The Frequency of Leukocytes and Nitrites in the Urine of Healthy Adults

Kendall Healthcare Group, Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
False Positive Urine

研究概览

简要总结

This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.

详细描述

The urinalysis (UA) is one of the most commonly utilized tests in the emergency department (ED). In some busy EDs, a UA is routinely ordered by protocol on patients with abdominal pain, and in elderly patients, a UA is often ordered for a variety of chief complaints including dizziness and altered mental status. When these patients, who often do not specifically have symptoms of a urinary tract infection, have a urinalysis demonstrating pyuria or bacteria, it may be interpreted as an atypical presentation of a UTI. However, it is possible that these patients do not have urinary tract infections, but have baseline pyuria or bacteriuria. One prior study found that 5% of sexually active healthy women 18-40 have asymptomatic bacteriuria [1], and the rate of asymptomatic bacteriuria increases with age, such that it is present in 8-10% of women from 70-80 years of age [2]. Moreover, one prior article stated that 30-50% of residents of long term nursing facilities have positive urine cultures at any given time [3].

The above statistics come from the results of urine cultures. In the ED, the decision to treat or not treat a patient for a UTI is not made based upon culture results, but upon a urinalysis (microscopic or dipstick). Only one prior study has looked at the frequency of abnormal urinalyses in healthy individuals, and it found that over a third of asymptomatic women had at least 1+ leukocytes in their urine [4]. This is evidence that a substantial number of people who do not have symptomatic UTIs have UAs that could be interpreted as UTIs. If these results could be replicated and expanded to include a wider group of individuals (males, elderly patients, various races, etc.), it would provide valuable information about how we can better interpret and utilize the results of a UA.

Thus, the investigators propose a prospective study to assess the frequency of abnormal UAs in a wide variety of individuals without acute symptoms.

Urine samples will be obtained from adults with no acute symptoms, and performed urine dipsticks to assess the frequency of leukocytes or nitrites in the urine. Patients will be divided into groups to determine if there are certain factors (gender, age, or medical history) that increase the chance of having leukocytes or nitrites in the urine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Able to spontaneously provide a urine sample

排除标准

  • Any acute symptoms (including but not limited to vaginal bleeding, vaginal discharge, abdominal pain, back pain, dysuria, hematuria, and fever)
  • Pregnancy
  • Prisoner status
  • Antibiotics within 72 hours
  • Urologic procedure within a week

结局指标

主要结局

False Positive Urine

时间窗: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.

A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a "false positive urine".

次要结局

  • Incidental Hematuria(The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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