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

This study has been completed.
Sponsor:
Information provided by:
Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:
NCT00621114
First received: January 31, 2008
Last updated: January 26, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Hemodialysis
 Device: GamCath® central venous catheter
Device: GamCath Dolphin® Protect central venous catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Gambro Dialysatoren GmbH:

Primary Outcome Measures:
  • Bacterial colonisation of the catheter surface [ Time Frame: after explantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • venous and arterial pressure [ Time Frame: during dialysis ] [ Designated as safety issue: No ]
  • catheter dwell time [ Time Frame: at explantation ] [ Designated as safety issue: No ]
  • exit site appearance [ Time Frame: at routine catheter care ] [ Designated as safety issue: No ]
  • blood parameters [ Time Frame: during dialysis ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: GamCath Dolphin® Protect

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621114

Locations
Germany
Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
Gambro Dialysatoren GmbH
Investigators
Principal Investigator: Teut Risler, Prof. Dr. Universitaetsklinikum Tuebingen
  More Information

No publications provided

Responsible Party: Manager Clinical Research, Gambro Dialysatoren GmbH (Germany)
ClinicalTrials.gov Identifier: NCT00621114     History of Changes
Other Study ID Numbers: Study No 2007_MBR_003, ISRCTN39140035
Study First Received: January 31, 2008
Last Updated: January 26, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gambro Dialysatoren GmbH:
Dialysis, Extracorporeal
Dialysis, Renal
Extracorporeal Dialysis
Hemodialysis

ClinicalTrials.gov processed this record on May 21, 2013