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Poor recruitment
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
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This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultraviolet arm | Experimental | This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultraviolet light emitting optical fiber | Device | A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn. |
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| Measure | Description | 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. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabeel Akhter, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Measured at study end, expected at 1 year. |