AgION Catheter for Preventing Catheter-Related Bloodstream Infections

Not Applicable

Completed

• Conditions: Catheter-Related Infections
• Interventions: Device: Umbilical catheterization (ArgyleTM); Device: Umbilical catheterization (AgION )

• Registration Number: NCT01564615
• Lead Sponsor: University of Florence

Brief Summary

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

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 Timeline

• Study Start: 2007-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-27
• Last Update Submitted: 2012-03-27
• Study First Posted: 2012-03-28
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-impregnated polyurethane catheter	Umbilical catheterization (ArgyleTM)	Patients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
AgION catheter	Umbilical catheterization (AgION )	Patients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).

Primary Outcome Measures

Name	Time	Method
Incidence of CRBSIs	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 Outcome Measures

Name	Time	Method
Case fatality rate for infants with CRBSI	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.
AgION catheters tolerability	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).
Infection density	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.
Likelihood of freedom from CRIBSIs	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

Trial Locations

Locations (1)

Careggi Univesity Hospital; 🇮🇹 Florence, Italy