A Parallel, Randomized Multicenter Comparison of Triple Lumen Central Venous Catheters Impregnated With Silver Nanoparticles (AgTive®) Versus Conventional Catheters in Intensive Care Unit Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 472
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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
Detailed Description
RATIONALE
Central venous catheter (CVC) infections are one of the major causes of infections acquired in intensive care unit (ICU) patients. About 25% of bloodstream infections recorded in ICUs are secondary to proven catheter-related infections and up to 80% of the so-called primary bacteraemia may be caused by catheters. Pittet et al. have estimated that nosocomial bloodstream infection, irrespective of its source, was associated with an overall 35% attributable mortality and a prolonged hospital stay of 32 days, including 8 days in the ICU. Prevention of catheter-related infections is a priority for infection control programs. Clear preventive measures include strict barrier precautions during insertion and careful aseptic techniques during subsequent manipulations of catheters. Other preventive measures, including the use of catheters specifically designed to inhibit microbial colonisation, such as antimicrobial-coated catheters, are not universally accepted or recommended for routine use, also due to their high cost. Previous trials have demonstrated a 50% risk reduction of infection rates when using antiseptic-coated catheters; however, their efficacy in reducing catheter related bloodstream infections is still unclear. A new generation of silver nanoparticle impregnated CVCs (Logicath AgTive®, Medex Medical INC., UK), has become recently available, but no clinical trial documenting their activity in preventing microbial colonization of catheters has been carried out so far. In this study, we want to assess the ability of this new generation catheters to prevent short-term (< 28 days) catheter-related infections in critically ill patients, in comparison with conventional untreated catheters.
STUDY POPULATION
All consecutively admitted critically ill patients needing central venous catheterization for more than 5 days.
TRIAL OBJECTIVE AND PURPOSE
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A
in this arm conventional CVCs will be inserted
Intervention: CVC cannulation (Procedure)
B
group B will receive medicated silver nanoparticles CVC
Intervention: CVC impregnated with silver nanoparticles (AgTive®) (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- 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)