Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application

Study Overview
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Brief Summary
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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.

Detailed Description
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Central venous catheters are increasingly used to provide long-term venous access, e.g. after failure of the primary arteriovenous fistula, and they are the first choice in case of an acute need for extracorporeal therapy. Microbial adhesions and biofilm formation have been implicated in serious infections associated with the use of indwelling catheters. 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. The clinical study described below aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections.

Official Title
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Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application

Conditions
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Hemodialysis

Intervention / Treatment
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* Device: GamCath® central venous catheter
* Device: GamCath Dolphin® Protect central venous catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients in group 1 will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891). | Device: GamCath® central venous catheter<br>* Choice of central venous catheter type<br>* Other names: GamCath® catheter;|
| Experimental: 2<br>Patients in group 2 will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671). | Device: GamCath Dolphin® Protect central venous catheter<br>* Choice of central venous catheter type<br>* Other names: GamCath Dolphin® Protect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial colonisation of the catheter surface |  | after explantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous and arterial pressure |  | during dialysis | 
| catheter dwell time |  | at explantation | 
| exit site appearance |  | at routine catheter care | 
| blood parameters |  | during dialysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis, Hemodialysis