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

Sponsored by:	B. Braun Melsungen AG
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00555282

Purpose

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®.

Condition	Intervention	Phase
Bacteriaemia Catheter Related Bloodstream Infection	Device: central venous catheter	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:

Incidence of catheter colonization [ Time Frame: after catheter removal ] [ Designated as safety issue: No ]
Incidence of bloodstream infection [ Time Frame: during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization [ Time Frame: catheter removal ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	680
Study Start Date:	November 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental coated central venous catheter	Device: central venous catheter coated central venous catheter
2: Active Comparator standard central venous catheter	Device: central venous catheter standard central venous catheter

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®.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555282

Locations

Czech Republic
Faculty Hospital Charles University	Recruiting
Prague, Czech Republic, 100 00
Contact: Jan Pachl, Prof. Dr. +420 26716 ext 2451 pachl@fnkv.cz
Sub-Investigator: Pavel Jansky, Dr.
Sub-Investigator: Petr Mizner, Dr.
Sub-Investigator: Tomas Balik, Dr.
Sub-Investigator: Zuzana Ilgova, Dr.
Sub-Investigator: Martin Kolar, Dr.
Sub-Investigator: Jan Turek, Dr.
Principal Investigator: Jan Pachl, Prof.
Faculty Hospital Brno	Recruiting
Brno, Czech Republic, 662 43
Contact: Pavel Sevcik, Prof. Dr. +420 532233850 psevcik@med.muni.cz
Sub-Investigator: Ivo Krikava, Dr.
Sub-Investigator: Barbora Garajova, Dr.
Sub-Investigator: Jitka Hillova-Mannova, Dr.
Sub-Investigator: Roman Maly, Dr.
Principal Investigator: Pavel Sevcik, Prof.

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

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

More Information

Responsible Party:	B. Braun Melsungen AG ( Dr. Ute Brauer )
Study ID Numbers:	HC-G-H-0507
Study First Received:	November 7, 2007
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00555282
Health Authority:	Czech Republic: Ethics Committee

Keywords provided by B. Braun Melsungen AG:

central venous catheter
cvc
coated catheter
bacteriaemia
bloodstream infection

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Sepsis
Bacteremia
Inflammation

Additional relevant MeSH terms:

Communicable Diseases
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 15, 2009