Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

Ultraviolet Interventions

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Catheter-Related Infections

Interventions

Ultraviolet light emitting optical fiberDEVICE

A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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