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

February 4, 2010 updated by: B. Braun Melsungen AG

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

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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®.

Study Type

Interventional

Enrollment (Actual)

680

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 662 43
        • Faculty Hospital Brno
      • Prague, Czech Republic, 100 00
        • Faculty Hospital Charles University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
coated central venous catheter
Device: central venous catheter
coated central venous catheter
Other Names:
  • Certofix Protect
Device: central venous catheter
standard central venous catheter
Other Names:
  • Certofix Trio
Active Comparator: 2
standard central venous catheter
Device: central venous catheter
coated central venous catheter
Other Names:
  • Certofix Protect
Device: central venous catheter
standard central venous catheter
Other Names:
  • Certofix Trio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of catheter colonization
Time Frame: after catheter removal
after catheter removal
Incidence of bloodstream infection
Time Frame: during treatment
during treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Jan Pachl, Prof. Dr., Faculty Hospital Charles University Prague
  • Principal Investigator: Pavel Sevcik, Prof. Dr., Brno University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (Estimate)

November 8, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2010

Last Update Submitted That Met QC Criteria

February 4, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-G-H-0507

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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