Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)

Study Overview
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Brief Summary
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The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.

Detailed Description
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Central venous catheters are an essential part of patient management in the ICU (Intensive Care Unit). The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Many catheters become colonized with bacteria but only a proportion of colonised catheters go on to cause bacteriemia and sepsis. It is currently impossible to prospectively identify which of the catheters will become colonized and lead to sepsis. Various types of antiseptic or antimicrobial vascular catheter coatings have been developed. Studies showed that the coated catheters were effective in limiting the catheter colonization rate and that they may decrease the risk of catheter-related bloodstream infections. The Certofix protect was developed by B.Braun to reduce the risk of catheter related infections. It is a catheter with a modified surface that consists of a high molecular weight polymer which is non-covalently linked to the polyurethane catheter material. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.

Official Title
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Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of a Standard Central Venous Catheter (CVC) in Comparison to a Coated CVC

Conditions
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Bacteriaemia, Catheter Related Bloodstream Infection

Intervention / Treatment
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* Device: central venous catheter
* Device: central venous catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with probable ICU stay Patient's first or second catheter placement during actual hospital stay Anticipated indwelling central venous catheter period >= 3 days (jugular vein, subclavian vein) >= 18 years of age Written informed consent of patient or independent physician prior to the participation; in this case: written informed consent after recovery if possible Exclusion Criteria: The catheter will not be placed in the femoral vein Inflammation of the skin at the site of puncture prior to puncture Known hypersensitivity to any of the components (i.e. polyhexanide or related substances such as chlorhexidine) Participation in another clinical trial Emergency insertion of catheter in the field

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>coated central venous catheter | Device: central venous catheter<br>* coated central venous catheter<br>* Other names: Certofix Protect;|
| Active Comparator: 2<br>standard central venous catheter | Device: central venous catheter<br>* standard central venous catheter<br>* Other names: Certofix Trio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of catheter colonization |  | after catheter removal | 
| Incidence of bloodstream infection |  | during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of catheter: complications related to the catheter and adverse events in general, clinical therapy, TISS-Score, ICU stay, infection markers |  | until discharge from ICU | 
| Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization |  | catheter removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous catheter, cvc, coated catheter, bacteriaemia, bloodstream infection