AgION Catheter for Preventing Catheter-Related Bloodstream Infections

Catheter-Related Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564615
• Other study ID #: 01/2012
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: March 27, 2012
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2012
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-Related Infections
• Communicable Diseases
• Infection

Intervention

Device:
• Umbilical catheterization (AgION )
Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
• Umbilical catheterization (ArgyleTM)
Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)

Locations

Country	Name	City	State
Italy	Careggi Univesity Hospital	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CRBSIs	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	No
Secondary	Infection density	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	Yes
Secondary	Likelihood of freedom from CRIBSIs	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	No
Secondary	AgION catheters tolerability	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	Yes
Secondary	Case fatality rate for infants with CRBSI	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	No