Comparison of Central Venous Catheters With Silver Nanoparticles Versus Conventional Catheters - Full Text View

Sponsors and Collaborators:	Catholic University of the Sacred Heart ISS, Dip.Tecnologie e Salute, Prof. Gianfranco Donelli
Information provided by:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00337714

Purpose

Bloodstream infections are common in Intensive Care Units (ICUs). The need of a central venous line increases the risk of bacteremia and central venous catheter (CVC) related infections. The use of catheters coated and/or impregnated with different antimicrobial agents has been proposed to reduce the risk of such infections. However, results obtained so far did not reach enough clinical relevance to consider these medicated catheters as a valid alternative to the conventional ones.

The aim of this comparative randomized study is to assess the ability of recently developed silver ion-releasing central venous catheters in preventing associated infections in comparison with the conventional ones.

Experimental groups are defined as follows:

Group A: patients treated with standard, triple lumen, non medicated catheters
Group B: patients treated with triple lumen catheters impregnated with silver nanoparticles

Condition	Intervention	Phase
Central Venous Catheter Related Infections	Procedure: CVC impregnated with silver nanoparticles (AgTive®) Procedure: CVC cannulation	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Parallel, Randomized Multicenter Comparison of Triple Lumen Central Venous Catheters Impregnated With Silver Nanoparticles (AgTive®) Versus Conventional Catheters in Intensive Care Unit Patients

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

The primary end-point is the difference in raw percentage occurrence of central venous catheter related infections (CVCRI) (on a patient basis) between groups A and B. [ Time Frame: period during the ICU stay ]

Secondary Outcome Measures:

The secondary end-point are the infection-free time and the probability of CVCRI as a function of multiple predictors. [ Time Frame: period during the ICU stay ]

Estimated Enrollment:	472
Study Start Date:	July 2006
Estimated Study Completion Date:	September 2008

Arms	Assigned Interventions
A: Placebo Comparator in this arm conventional CVCs will be inserted	Procedure: CVC cannulation placement of conventional trilumen CVCs
B: Active Comparator group B will receive medicated silver nanoparticles CVC	Procedure: CVC impregnated with silver nanoparticles (AgTive®) insertion of medicated silver nanoparticles CVC

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Eligibility

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

Criteria

Inclusion Criteria:

Patients will be eligible when insertion of a central venous catheter (CVC) at a new site (subclavian or internal jugular) has to be planned for therapy or monitoring of at least 3-day duration.

Exclusion Criteria:

Age below 18 years and all patients with a history of failed catheterization attempts or the need for catheterization at a site of previous surgery, skeletal deformity, or scarring.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337714

Contacts

Contact: Massimo Antonelli, Prof	+39 06 30 15 3226	m.antonelli@rm.unicatt.it
Contact: Gianfranco Donelli, Prof	+ 39 06 4990 22 28	donelli@iss.it

Locations

Italy
UCSC, Policlinico Universitario A. Gemelli, ICU	Recruiting
Rome, Italy, 00168
Contact: Massimo Antonelli, Prof +39 06 30 15 32 26 m.antonelli@rm.unicatt.it
Contact: Mariano A Pennisi, Dr + 39 06 30 15 43 86 mpennisi@rm.unicatt.it
Principal Investigator: Massimo Antonelli, Prof

Sponsors and Collaborators

Catholic University of the Sacred Heart

ISS, Dip.Tecnologie e Salute, Prof. Gianfranco Donelli

Investigators

Study Chair:

Massimo Antonelli, Prof

Università Cattolica del Sacro Cuore

More Information

center for randomization and data collection This link exits the ClinicalTrials.gov site

Study ID Numbers:	60% MURST no. 7020119-1
Study First Received:	June 14, 2006
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00337714
Health Authority:	Italy: National Institute of Health

Keywords provided by Catholic University of the Sacred Heart:

Central venous catheter,
bloodstream infections,
intensive care unit

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009