NCT02899780撤回不适用
Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Ultraviolet Interventions2 个研究点 分布在 1 个国家开始时间: 2017年5月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
研究概览
简要总结
This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Be at least 18 years of age
- •Have the ability to provide informed consent
- •Have an implanted dialysis catheter of one of the following models: Medcomp Titan 15.5F x 24 cm or Medcomp Titan 15.5F x 28 cm
- •Positive blood culture drawn from the catheter
排除标准
- •Previous inclusion in study
研究组 & 干预措施
Ultraviolet arm
Experimental
This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber.
干预措施: Ultraviolet light emitting optical fiber (Device)
结局指标
主要结局
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
时间窗: Measured immediately after UV treatment
Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter
时间窗: Measured at study end, expected at 1 year.
次要结局
- Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters(Measured after UV treatment, with results expected in 5 days.)
- Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.(Measured at study end, expected at 1 year.)
研究者
研究点 (2)
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