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

Catheter Related Bloodstream Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555282
• Other study ID #: HC-G-H-0507
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2007
• Last updated: February 4, 2010
• Start date: November 2005
• Est. completion date: July 2009

Study information

• Verified date: February 2010
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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®.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia
• Bacteriaemia
• Catheter Related Bloodstream Infection
• Communicable Diseases
• Infection

Intervention

Device:
• central venous catheter
coated central venous catheter
• central venous catheter
standard central venous catheter

Locations

Country	Name	City	State
Czech Republic	Faculty Hospital Brno	Brno
Czech Republic	Faculty Hospital Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter colonization		after catheter removal	No
Primary	Incidence of bloodstream infection		during treatment	No
Secondary	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	Yes
Secondary	Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization		catheter removal	Yes