Ex Vivo Microbiological Assessment of an Anti-Biofilm Catheter in Acute Dialysis Application - Full Text View

Sponsored by:	Gambro Dialysatoren GmbH
Information provided by:	Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:	NCT00621114

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

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Ex Vivo Microbiological Assessment of an Anti-Biofilm Catheter in Acute Dialysis Application

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 ]

Estimated Enrollment:	69
Study Start Date:	August 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Experimental 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

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

Contacts

Contact: Heike B Lebsanft, Dr.	+49 (0) 7471 17 2008	heike.lebsanft@gambro.com
Contact: Werner Beck, Dr.	+49 (0) 7471 17 1259	werner.beck@gambro.com

Locations

Germany
Universitaetsklinikum Tuebingen	Recruiting
Tuebingen, Germany, 72076
Contact: Teut Risler, Prof. Dr. 0049 - (0) 7071 - 29-83149 teut.risler@uni-tuebingen.de
Contact: Nils Heyne, Dr. med. 0049 - (0)7071-29-82855 nils.heyne@med.uni-tuebingen.de
Principal Investigator: Teut Risler, Prof. Dr.
Sub-Investigator: Nils Heyne, Dr. med.

Sponsors and Collaborators

Gambro Dialysatoren GmbH

Investigators

Principal Investigator:

Teut Risler, Prof. Dr.

Universitaetsklinikum Tuebingen

More Information

Responsible Party:	Gambro Dialysatoren GmbH (Germany) ( Manager Clinical Research )
Study ID Numbers:	Study No 2007_MBR_003, ISRCTN39140035
Study First Received:	January 31, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00621114
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 January 16, 2009