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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN39140035 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| Gambro Dialysatoren GmbH | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.
Central venous catheters are increasingly used to provide long-term venous access, e.g. after failure of the primary arteriovenous fistula, and they are the first choice in case of an acute need for extracorporeal therapy. Microbial adhesions and biofilm formation have been implicated in serious infections associated with the use of indwelling catheters.
In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.
The clinical study described below aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Patients in group 1 will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891). |
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| 2 | Experimental | Patients in group 2 will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GamCath® central venous catheter | Device | Choice of central venous catheter type |
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| Measure | Description | Time Frame |
|---|---|---|
| Bacterial colonisation of the catheter surface | after explantation |
| Measure | Description | Time Frame |
|---|---|---|
| venous and arterial pressure | during dialysis | |
| catheter dwell time | at explantation | |
| exit site appearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teut Risler, Prof. Dr. | Universitaetsklinikum Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
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| GamCath Dolphin® Protect central venous catheter | Device | Choice of central venous catheter type |
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| at routine catheter care |
| blood parameters | during dialysis |