Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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).

Group Type ACTIVE_COMPARATOR

GamCath® central venous catheter

Intervention Type DEVICE

Choice of central venous catheter type

2

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).

Group Type EXPERIMENTAL

GamCath Dolphin® Protect central venous catheter

Intervention Type DEVICE

Choice of central venous catheter type

Interventions

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GamCath® central venous catheter

Choice of central venous catheter type

Intervention Type DEVICE

GamCath Dolphin® Protect central venous catheter

Choice of central venous catheter type

Intervention Type DEVICE

Other Intervention Names

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GamCath® catheter GamCath Dolphin® Protect

Eligibility Criteria

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Inclusion Criteria

* central venous catheter placement
* Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
* Anticipated duration of dialysis therapy less than or equal to 30 days
* Age between 18 and 85 years
* Written informed consent