Comparison of Central Venous Catheters With Silver Nanoparticles Versus Conventional Catheters

NCT00337714 | Completed Phase 4

• 1 other identifier: 60% MURST no. 7020119-1
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

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

Conditions

Central Venous Catheter Related Infections

Keywords

Central venous catheter,; bloodstream infections,; intensive care unit

Outcome Measures

Primary Outcomes (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.

  period during the ICU stay

Secondary Outcomes (1)

• The secondary end-point are the infection-free time and the probability of CVCRI as a function of multiple predictors.

  period during the ICU stay

Study Arms (2)

A

PLACEBO COMPARATOR

in this arm conventional CVCs will be inserted

Procedure: CVC cannulation

B

ACTIVE COMPARATOR

group B will receive medicated silver nanoparticles CVC

Procedure: CVC impregnated with silver nanoparticles (AgTive®)

Interventions

CVC impregnated with silver nanoparticles (AgTive®) PROCEDURE

insertion of medicated silver nanoparticles CVC

B

CVC cannulation PROCEDURE

placement of conventional trilumen CVCs

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• ISS, Dip.Tecnologie e Salute, Prof. Gianfranco Donelli: collaborator

Study Sites (1)

UCSC, Policlinico Universitario A. Gemelli, ICU

Rome, Rome, 00168, Italy

Location

Related Links

• Related Info

MeSH Terms

Conditions

Sepsis

Interventions

colloidal silver

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Antonelli, Prof

  Catholic University of the Sacred Heart

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: July 1, 2006
• Study Completion: September 1, 2008
• Last Updated: May 16, 2011

Record last verified: 2008-09

Locations

IT (1)