Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

Overview

This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 10, 2018

Interventions

  • Device: Ultraviolet light emitting optical fiber
    • A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.

Arms, Groups and Cohorts

  • Experimental: Ultraviolet arm
    • This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • Previous inclusion in study – Pregnant

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ultraviolet Interventions
  • Collaborator
    • University of Maryland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nabeel Akhter, MD, Principal Investigator, University of Maryland Medical Center

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