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

Hemodialysis Clinical Trial

— ABBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621114
• Other study ID #: Study No 2007_MBR_003
• Secondary ID: ISRCTN39140035
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: April 19, 2017
• Start date: August 2007
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Device:
• GamCath® central venous catheter
Choice of central venous catheter type
• GamCath Dolphin® Protect central venous catheter
Choice of central venous catheter type

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial colonisation of the catheter surface		after explantation
Secondary	venous and arterial pressure		during dialysis
Secondary	catheter dwell time		at explantation
Secondary	exit site appearance		at routine catheter care
Secondary	blood parameters		during dialysis