Ex vivo microbiological assessment of an anti-biofilm catheter in acute dialysis applicatio
Not Applicable
Completed
- Conditions
- Renal diseaseUrological and Genital Diseases
- Registration Number
- ISRCTN39140035
- Lead Sponsor
- Gambro Dialysatoren GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 69
Inclusion Criteria
1. Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
2. Anticipated duration of dialysis therapy less than or equal to 30 days
3. Age between 18 and 85 years
4. Written informed consent
Exclusion Criteria
1. Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection
2. Known pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Bacterial colonisation of the catheter surface, analysed after removal of the catheter. A cut-off 100 CFU/mL will be defined as positive<br> 2. Bismuth content in plasma and lock solution will be analysed before catheter placement, once weekly pre-dialysis and once at explantation<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Catheter patency (indirect measure: venous and arterial pressure differences)<br> 2. Catheter dwell time<br> 3. Exit site appearance<br> 4. Blood parameters<br><br> Secondary outcome measured will be documented at routine sampling.<br>