Clinical assessment of a new catheter surface coating with antimicrobial properties: efficacy and effect of intensive catheter and exit site care educatio
Not Applicable
Completed
- Conditions
- Renal diseaseUrological and Genital Diseases
- Registration Number
- ISRCTN93939200
- Lead Sponsor
- Gambro Dialysatoren GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
1. Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
2. Age over 18 years
3. Written informed consent
4. Needed catheter length 15 cm or 20 cm
Exclusion Criteria
1. Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
2. Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
3. Bacteremia with a former catheter within 10 days prior to catheter implantation
4. Known pregnancy
5. Lactation
6. Participation in another clinical study during the preceding 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Bacterial colonisation of the catheter surface.<br><br> The time points of catheter analysis cannot be given exactly as these analyses are done after removal of the catheter and removal is determined by medical indication not influenced by the study protocol. The other sampling points and number of analyses are also depending on the individual patient?s treatment regimen. The maximal observation period is 29 days.<br>
- Secondary Outcome Measures
Name Time Method