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

Phase 4

Completed

• Conditions: Catheter Related Bloodstream Infection; Bacteriaemia

• Registration Number: NCT00555282
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

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

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2007-11-07
• Study First Submitted QC: 2007-11-07
• Study First Posted: 2007-11-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-04
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 680

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of bloodstream infection	during treatment
Incidence of catheter colonization	after catheter removal

Secondary Outcome Measures

Name	Time	Method
Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization	catheter removal
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

Trial Locations

Locations (2)

Faculty Hospital Brno; 🇨🇿 Brno, Czech Republic

Faculty Hospital Charles University; 🇨🇿 Prague, Czech Republic