Clinical trial NCT00555282: Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacteriaemia
Catheter Related Bloodstream Infection
Keywords: central venous catheter
cvc
coated catheter
bacteriaemia
bloodstream infection
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2007-11-08
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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®.

Eligibility 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

Primary outcomes:
measure: Incidence of catheter colonization
timeFrame: after catheter removal
measure: Incidence of bloodstream infection
timeFrame: during treatment
Secondary outcomes:
measure: Safety of catheter: complications related to the catheter and adverse events in general, clinical therapy, TISS-Score, ICU stay, infection markers
timeFrame: until discharge from ICU
measure: Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization
timeFrame: catheter removal
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Faculty Hospital Brno
city: Prague
country: Czech Republic
facility: Faculty Hospital Charles University
Study officials:
affiliation: Faculty Hospital Charles University Prague
name: Jan Pachl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brno University Hospital
name: Pavel Sevcik, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krikava I, Kolar M, Garajova B, Balik T, Sevcikova A, Roschke I, Sevcik P. The efficacy of a non-leaching antibacterial central venous catheter - a prospective, randomized, double-blind study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Jun;164(2):154-160. doi: 10.5507/bp.2019.022. Epub 2019 May 28.