Clinical Trial: Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Brief Summary: This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.
Detailed Summary:
Sponsor: Ultraviolet Interventions
Current Primary Outcome:
- Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter [ Time Frame: Measured immediately after UV treatment ]
- Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter [ Time Frame: Measured at study end, expected at 1 year. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters [ Time Frame: Measured after UV treatment, with results expected in 5 days. ]
- Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage. [ Time Frame: Measured at study end, expected at 1 year. ]
Original Secondary Outcome: Same as current
Information By: Ultraviolet Interventions
Dates:
Date Received: August 27, 2016
Date Started: April 2017
Date Completion: April 2018
Last Updated: April 5, 2017
Last Verified: April 2017