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临床试验/NCT01570556
NCT01570556Unknown4 期

Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
4 期
入组人数
120
试验地点
2
主要终点
Change in serum inflammatory markers (CRP, IL-6)

研究概览

简要总结

When considering occult infections during the diagnostic workup of inflammation in Hemodialysis (HD) patients, the urine-deprived bladder is frequently dismissed as potential site of infection. The urinary tract, even in end stage renal disease (ESRD) patients on hemodialysis may represent a significant reservoir for infection. Delayed diagnosis is a relevant issue because the urinary tract is often overlooked as a source of infection in dialysis patients, especially because of absence of urinary tract infection (UTI) symptoms in HD patients. Contributing factors to asymptomatic UTI in HD patients include the presence of low urine volume, bladder stasis, and the fact that UTI symptoms are mostly related to voiding, which is reduced or absent in these patients. Persistence of asymptomatic bacteriuria and UTI may be related to higher levels of inflammatory markers in HD population. In view of the association between cardiovascular disease and cardio-vascular and all-cause mortality with inflammation, as expressed by elevated CRP and/or IL-6 levels in HD patients, the investigators questioned whether presence of asymptomatic UTI could contribute to elevated levels of inflammatory markers in patients with ESRD on maintenance HD therapy. Such a finding would provide a potential link between a treatable infection and a potential cardiovascular risk factor in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months
  • Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and hemodialysis performed at least 3 times weekly
  • Patients with native A-V Fistula or graft
  • Informed consent obtained before any trial-related activities

排除标准

  • Patients with an indwelling catheters
  • Patients with periodontitis
  • Patients with diabetic foot
  • Patients with active malignant disease or liver cirrhosis
  • Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)
  • Patients treated with immunosuppressive agents
  • Patients suffering from
  • Acute vasculitis
  • Severe systemic infections
  • Heart failure (NYHA class III-IV)

结局指标

主要结局

Change in serum inflammatory markers (CRP, IL-6)

时间窗: 3 months, 6 months, and 12 months

次要结局

  • Cardio-vascular events(3 months, 6 months and 12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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