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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

November 7, 2007
February 4, 2010
November 2005
July 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Incidence of catheter colonization [ Time Frame: after catheter removal ]
  • Incidence of bloodstream infection [ Time Frame: during treatment ]
Complete list of historical versions of study NCT00555282 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization [ Time Frame: catheter removal ]
Not Provided
Not Provided
 
Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)
Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of a Standard Central Venous Catheter (CVC) in Comparison to a Coated 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®.

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®.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Bacteriaemia
  • Catheter Related Bloodstream Infection
  • Device: central venous catheter
    coated central venous catheter
    Other Name: Certofix Protect
  • Device: central venous catheter
    standard central venous catheter
    Other Name: Certofix Trio
  • Experimental: 1
    coated central venous catheter
    Intervention: Device: central venous catheter
  • Active Comparator: 2
    standard central venous catheter
    Intervention: Device: central venous catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
680
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00555282
HC-G-H-0507
Not Provided
Dr. Ute Brauer, B. Braun Melsungen AG
B. Braun Melsungen AG
Not Provided
Principal Investigator: Jan Pachl, Prof. Dr. Faculty Hospital Charles University Prague
Principal Investigator: Pavel Sevcik, Prof. Dr. Brno University Hospital
B. Braun Melsungen AG
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP