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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-07-31

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®.

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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®.

Conditions

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Bacteriaemia Catheter Related Bloodstream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

coated central venous catheter

Group Type EXPERIMENTAL

central venous catheter

Intervention Type DEVICE

coated central venous catheter

2

standard central venous catheter

Group Type ACTIVE_COMPARATOR

central venous catheter

Intervention Type DEVICE

standard central venous catheter

Interventions

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central venous catheter

coated central venous catheter

Intervention Type DEVICE

central venous catheter

standard central venous catheter

Intervention Type DEVICE

Other Intervention Names

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Certofix Protect Certofix Trio

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No