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