Status:
COMPLETED
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Gambro Dialysatoren GmbH
Baxter Healthcare Corporation
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care ed...
Detailed Description
The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused ...
Eligibility Criteria
Inclusion
- central venous catheter placement
- Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
- Age over 18 years
- Written informed consent
- Needed catheter length 15 cm or 20 cm
Exclusion
- Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
- Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
- Bacteremia with a former catheter within 10 days prior to catheter implantation
- Known pregnancy
- Lactation
- Participation in another clinical study during the preceding 30 days
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00621712
Start Date
October 1 2007
End Date
December 1 2010
Last Update
March 13 2025
Active Locations (1)
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1
St. Joseph-Krankenhaus Berlin
Berlin, Germany, 12101