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OpenTrials
Completed

NCT Number: NCT00555282

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

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Key information

Conditions

Bacteriaemia Catheter Related Bloodstream Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty Hospital Brno, Brno, Czechia

Loading trial locations.

About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Central Venous Catheter

Device

coated central venous catheter

Other names: Certofix Protect

Primary outcomes

  1. Incidence of catheter colonization

    Time frame: after catheter removal

  2. Incidence of bloodstream infection

    Time frame: during treatment

Secondary outcomes

  1. 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

  2. Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization

    Time frame: catheter removal

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 8, 2007
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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