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

April 19, 2017 updated by: Baxter Healthcare Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Device: GamCath® central venous catheter
Choice of central venous catheter type
Other Names:
  • GamCath® catheter
Experimental: 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).
Device: GamCath Dolphin® Protect central venous catheter
Choice of central venous catheter type
Other Names:
  • GamCath Dolphin® Protect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacterial colonisation of the catheter surface
Time Frame: after explantation
after explantation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

Gambro Dialysatoren GmbH

Investigators

  • Principal Investigator: Teut Risler, Prof. Dr., Universitaetsklinikum Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Study No 2007_MBR_003
  • ISRCTN39140035 (Registry Identifier: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis

Clinical Trials on GamCath® central venous catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe