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Sponsored by: |
Gambro Dialysatoren GmbH |
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Information provided by: | Gambro Dialysatoren GmbH |
ClinicalTrials.gov Identifier: | NCT00621114 |
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 |
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Hemodialysis |
Device: GamCath® central venous catheter Device: GamCath Dolphin® Protect central venous catheter |
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 |
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 |
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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).
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Device: GamCath® central venous catheter
Choice of central venous catheter type
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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).
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Device: GamCath Dolphin® Protect central venous catheter
Choice of central venous catheter type
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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. |
Principal Investigator: | Teut Risler, Prof. Dr. | Universitaetsklinikum Tuebingen |
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 |
Dialysis, Extracorporeal Dialysis, Renal Extracorporeal Dialysis Hemodialysis |