Hemodialysis Clinical Trial
— ABBAOfficial title:
Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
Verified date | January 2010 |
Source | Baxter Healthcare Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.
Status | Completed |
Enrollment | 69 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - central venous catheter placement - Need for extracorporeal renal replacement therapy (acute and chronic renal failure) - Anticipated duration of dialysis therapy less than or equal to 30 days - Age between 18 and 85 years - Written informed consent Exclusion Criteria: - Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection - Known pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Universitaetsklinikum Tuebingen | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation | Gambro Dialysatoren GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bacterial colonisation of the catheter surface | after explantation | ||
Secondary | venous and arterial pressure | during dialysis | ||
Secondary | catheter dwell time | at explantation | ||
Secondary | exit site appearance | at routine catheter care | ||
Secondary | blood parameters | during dialysis |
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