Back to resultsTreatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Primary Purpose
Catheter-Related Infections
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultraviolet light emitting optical fiber
Sponsored by
About this trial
This is an interventional treatment trial for Catheter-Related Infections
Eligibility Criteria
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
Sites / Locations
- University of Maryland Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultraviolet arm
Arm Description
This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber.
Outcomes
Primary Outcome Measures
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Secondary Outcome Measures
Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters
Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.
Full Information
NCT ID
NCT02899780
First Posted
August 27, 2016
Last Updated
October 27, 2018
Sponsor
Ultraviolet Interventions
Collaborators
University of Maryland
1. Study Identification
Unique Protocol Identification Number
NCT02899780
Brief Title
Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Official Title
Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Poor recruitment
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
May 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ultraviolet Interventions
Collaborators
University of Maryland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultraviolet arm
Arm Type
Experimental
Arm Description
This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber.
Intervention Type
Device
Intervention Name(s)
Ultraviolet light emitting optical fiber
Other Intervention Name(s)
Lumenati Fiber
Intervention Description
A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.
Primary Outcome Measure Information:
Title
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Time Frame
Measured immediately after UV treatment
Title
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 Outcome Measure Information:
Title
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.
Title
Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.
Time Frame
Measured at study end, expected at 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabeel Akhter, MD
Organizational Affiliation
University of Maryland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
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