Comparison of Central Venous Catheters With Silver Nanoparticles Versus Conventional Catheters (NanoAgCVC)
This study has been completed.
Sponsor:
Catholic University of the Sacred Heart
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
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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 May 16, 2013