Catheter-Related Infections
Conditions
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.
Interventions
DEVICEUltraviolet light emitting optical fiber
A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.
Sponsors
University of Maryland
Ultraviolet Interventions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter | Measured immediately after UV treatment |
| Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter | Measured at study end, expected at 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed