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

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00555282
First received: November 7, 2007
Last updated: February 4, 2010
Last verified: February 2010
  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 4

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

Enrollment: 680
Study Start Date: November 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
coated central venous catheter
Device: central venous catheter
coated central venous catheter
Other Name: Certofix Protect
Active Comparator: 2
standard central venous catheter
Device: central venous catheter
standard central venous catheter
Other Name: Certofix Trio

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Czech Republic
Faculty Hospital Brno
Brno, Czech Republic, 662 43
Faculty Hospital Charles University
Prague, Czech Republic, 100 00
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. Brno University Hospital
  More Information

No publications provided

Responsible Party: Dr. Ute Brauer, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00555282     History of Changes
Other Study ID Numbers: HC-G-H-0507
Study First Received: November 7, 2007
Last Updated: February 4, 2010
Health Authority: Czech Republic: Ethics Committee

Keywords provided by B. Braun Melsungen AG:
central venous catheter
cvc
coated catheter
bacteriaemia
bloodstream infection

Additional relevant MeSH terms:
Bacteremia
Communicable Diseases
Infection
Bacterial Infections
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014