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

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ClinicalTrials.gov Identifier: NCT00337714
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : May 16, 2011
Sponsor:
Collaborator:
ISS, Dip.Tecnologie e Salute, Prof. Gianfranco Donelli
Information provided by:
Catholic University of the Sacred Heart

Brief Summary:

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 or disease Intervention/treatment Phase
Central Venous Catheter Related Infections Procedure: CVC impregnated with silver nanoparticles (AgTive®) Procedure: CVC cannulation Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2006
Actual Study Completion Date : September 2008

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00337714     History of Changes
Other Study ID Numbers: 60% MURST no. 7020119-1
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: September 2008

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