Skip to main content
OpenTrials
Completed

NCT Number: NCT01564615

AgION Catheter for Preventing Catheter-Related Bloodstream Infections

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Catheter-Related Infections Infections

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Careggi Univesity Hospital

Florence, Italy, 50141

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical catheterization (AgION )

Device

Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).

Umbilical catheterization (ArgyleTM)

Device

Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 28, 2012
Registry last updated
Mar 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.