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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00621114

Acronym

ABBA

Enrollment

Registered

2008-02-22

Start date

2007-08-31

Completion date

2009-07-31

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis, Hemodialysis

Brief summary

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.

Detailed description

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.

Interventions

DEVICEGamCath® central venous catheter

Choice of central venous catheter type

DEVICEGamCath Dolphin® Protect central venous catheter

Choice of central venous catheter type

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Exclusion criteria

* Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection * Known pregnancy

Design outcomes

Primary

Measure	Time frame
Bacterial colonisation of the catheter surface	after explantation

Secondary

Measure	Time frame
venous and arterial pressure	during dialysis
catheter dwell time	at explantation
exit site appearance	at routine catheter care
blood parameters	during dialysis

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026