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

Not Applicable

Completed

• Conditions: Hemodialysis
• Interventions: Device: GamCath® central venous catheter; Device: GamCath Dolphin® Protect central venous catheter

• Registration Number: NCT00621114
• Lead Sponsor: Vantive Health LLC

Brief Summary

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.

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GamCath® central venous catheter	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).
2	GamCath Dolphin® Protect central venous catheter	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).

Primary Outcome Measures

Name	Time	Method
Bacterial colonisation of the catheter surface	after explantation

Secondary Outcome Measures

Name	Time	Method
venous and arterial pressure	during dialysis
catheter dwell time	at explantation
exit site appearance	at routine catheter care
blood parameters	during dialysis

Trial Locations

Locations (1)

Universitaetsklinikum Tuebingen; 🇩🇪 Tuebingen, Germany