AgION Catheter for Preventing Catheter-Related Bloodstream Infections

March 27, 2012 updated by: Carlo Dani, University of Florence

Reduction of Catheter-Related Bloodstream Infections in Preterm Infants by the Use of Catheters With the AgION Antimicrobial System

The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, a silver zeolite-impregnated catheter has been commercialized. This material, namely the patented silver compound AgION™, releases antimicrobially active silver ions which may help prevent catheter-related bloodstream infections CRBSIs which are frequent in preterm infant.

The investigators hypothesized that the use of AgION-impregnated umbilical catheters could decrease the occurrence of CRBSIs in preterm infants. To assess this hypothesis the investigators carried out a randomized controlled study in which preterm infants needing an umbilical vein catheter would received either an AgION catheter or a traditional non-impregnated polyurethane catheter.

Infants with gestational age < 30 weeks were randomized to receive an AgION- impregnated or non-impregnated polyurethane umbilical venous catheter (UVC) by opening sealed opaque envelopes. The primary end point was the incidence of CRBSIs during the time the UVC was in place.

The investigators studied 86 infants, 41 of whom received the AgION catheter and 45 the non-impregnated catheter. During umbilical venous catheterization 2% of infants in the AgION group developed CRBSI in comparison with 22% of infants in the control group (p=0.005). The incidence density of CRBSIs during the study period was lower in infants who received AgION catheters compared to the control group (2.1/1000 catheter days versus 25.8/1000 catheter days; p<0.001). The occurrence of UVC colonization was similar in both groups. The Kaplan-Meier estimates of the cumulative likelihood of being free of a CRBSI at each day of UVC placement demonstrate the statistically significant (p=0.004) protective effect of AgION impregnated catheters. Moreover, infants in the AgION group had shorter hospital stay (p=0.04), and a lower case fatality rate due to BSI (p=0.01) than infants in the control group.

AgION catheters were well tolerated and none of patients showed signs attributable to silver toxicity.

Multivariate analysis demonstrated that non-impregnated catheter use (OR 12.5, 95% C.l. 2.06-75.9) and catheter placement for more than 7 days (OR 5.1, 95% C.l. 1.13-23.6) increased the risk of developing a CRBSI in our population.

Conclusions. The AgION-impregnated UVCs were effective in decreasing the development of CRBSIs in preterm infants compared to non-impregnated polyurethane UVCs.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50141
        • Careggi Univesity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational age < 30 weeks
  • Need of an umbilical venous catheter in the first week of life
  • Parental informed consent.

Exclusion Criteria:

  • Major congenital malformations
  • Hydrops fetalis
  • Inherited congenital metabolic diseases
  • Death during the first week of life

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AgION catheter
Patients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Device: Umbilical catheterization (AgION )
Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Active Comparator: Non-impregnated polyurethane catheter
Patients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
Device: Umbilical catheterization (ArgyleTM)
Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of CRBSIs
Time Frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
We evaluated the incidence of CRBSIs (definite plus probable) during the time the UVC was in place.
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection density
Time Frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Number of infections/1000 catheter days, likelihood of freedom from CRIBSIS, and signs of catheter intolerance and possible adverse effects from silver ion toxicity were evaluated for the duration of umbilical venous catheterization; occurrence of BPD, IVH, PVL, ROP, and NEC, length of stay in hospital, case fatality rate for infants with CRBSI, and death were evaluated at discharge.
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Likelihood of freedom from CRIBSIs
Time Frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Likelihood of freedom from CRIBSIS for the duration of umbilical venous catheterization
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
AgION catheters tolerability
Time Frame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Signs of local intolerance, such as skin infection, were recorded. We also evaluated possible adverse effects from silver ion toxicity, such as the occurrence of argyria (blue-grey discoloration of the skin) or hepatic damage (i.e.: increase in AST/ALT enzymes).
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Case fatality rate for infants with CRBSI
Time Frame: Hospital stay duration, an expected average of 80 days
We evaluated the mortality caused by CRBSI in infants who received AgION-impregnated and non-impregnated groups.
Hospital stay duration, an expected average of 80 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Investigators

  • Principal Investigator: Carlo Dani, MD, Department of Surgical and Medical Critical Care, Section of Neonatology, University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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