Comparison of Central Venous Catheters With Silver Nanoparticles Versus Conventional Catheters (NanoAgCVC)

This study has been completed.
Sponsor:
Collaborator:
ISS, Dip.Tecnologie e Salute, Prof. Gianfranco Donelli
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00337714
First received: June 14, 2006
Last updated: May 13, 2011
Last verified: September 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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
Study Completion Date: September 2008
Arms Assigned Interventions
Placebo Comparator: A
in this arm conventional CVCs will be inserted
Procedure: CVC cannulation
placement of conventional trilumen CVCs
Active Comparator: B
group B will receive medicated silver nanoparticles CVC
Procedure: CVC impregnated with silver nanoparticles (AgTive®)
insertion of medicated silver nanoparticles CVC

  Show Detailed Description

  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

Locations
Italy
UCSC, Policlinico Universitario A. Gemelli, ICU
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
ISS, Dip.Tecnologie e Salute, Prof. Gianfranco Donelli
Investigators
Study Chair: Massimo Antonelli, Prof Catholic University of the Sacred Heart
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00337714     History of Changes
Other Study ID Numbers: 60% MURST no. 7020119-1
Study First Received: June 14, 2006
Last Updated: May 13, 2011
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:
Catheter-Related Infections
Infection

ClinicalTrials.gov processed this record on April 17, 2014