Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

Catheter-Related Infections Clinical Trial

Official title:

Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02899780
• Other study ID #: UVI-Pilot
• Status: Withdrawn
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: May 10, 2018

Study information

• Verified date: October 2018
• Source: Ultraviolet Interventions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 10, 2018
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections

Intervention

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A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Ultraviolet Interventions	University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter		Measured immediately after UV treatment
Primary	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	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.
Secondary	Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.		Measured at study end, expected at 1 year.