Clinical trial NCT00621712: Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
Official title: Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency
Keywords: Renal Dialysis
Dialysis, Extracorporeal
Dialysis, Renal
Extracorporeal Dialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Dialysatoren GmbH
name: Baxter Healthcare Corporation
First posted: 2008-02-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 education of the nursing staff on preventing central venous catheter-related infection.

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 on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation.

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.

Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections.

The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Bacterial colonisation of the catheter surface
timeFrame: at explantation
Secondary outcomes:
measure: Surface deposits of thrombogenic activity
timeFrame: at explantation
measure: Catheter survival
timeFrame: at explantation
measure: Exit site appearance
timeFrame: at routine catheter care
measure: Blood parameters
timeFrame: during dialysis
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: St. Joseph-Krankenhaus Berlin
Study officials:
affiliation: St. Joseph-Krankenhaus Berlin
name: Christiane M Erley, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: