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Completed

NCT Number: NCT00621114

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

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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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GamCath® central venous catheter

Device

Choice of central venous catheter type

Other names: GamCath® catheter

GamCath Dolphin® Protect central venous catheter

Device

Choice of central venous catheter type

Other names: GamCath Dolphin® Protect

Primary outcomes

  1. Bacterial colonisation of the catheter surface

    Time frame: after explantation

Secondary outcomes

  1. venous and arterial pressure

    Time frame: during dialysis

  2. catheter dwell time

    Time frame: at explantation

  3. exit site appearance

    Time frame: at routine catheter care

  4. blood parameters

    Time frame: during dialysis

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Dialysatoren GmbH

Registry information

Acronym: ABBA

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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