Renal Insufficiency
Conditions
Keywords
Renal Dialysis, Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis
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.
Interventions
choice of catheter type
choice of catheter type
Sponsors
Gambro Dialysatoren GmbH
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial colonisation of the catheter surface | at explantation |
Secondary
| Measure | Time frame |
|---|---|
| Surface deposits of thrombogenic activity | at explantation |
| Catheter survival | at explantation |
| Exit site appearance | at routine catheter care |
| Blood parameters | during dialysis |
Countries
Germany
Outcome results
None listed