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

Vantive Health LLC

Status: Completed

Conditions: Hemodialysis

Treatments: Device: GamCath Dolphin® Protect central venous catheter; Device: GamCath® central venous catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621114

ISRCTN39140035 (Registry Identifier)

Study No 2007_MBR_003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

1

Active Comparator group

Description:

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).

Treatment:

Device: GamCath® central venous catheter

2

Experimental group

Description:

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).

Treatment:

Device: GamCath Dolphin® Protect central venous catheter