Clinical trial NCT01564615: AgION Catheter for Preventing Catheter-Related Bloodstream Infections
Official title: Reduction of Catheter-Related Bloodstream Infections in Preterm Infants by the Use of Catheters With the AgION Antimicrobial System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Related Infections
Keywords: Catheter related bloodstream infection
Umbilical venous catheter
Silver
Preterm infants
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 86
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of CRBSIs
timeFrame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Secondary outcomes:
measure: Infection density
timeFrame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
measure: Likelihood of freedom from CRIBSIs
timeFrame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
measure: AgION catheters tolerability
timeFrame: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
measure: Case fatality rate for infants with CRBSI
timeFrame: Hospital stay duration, an expected average of 80 days
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi Univesity Hospital
Study officials:
affiliation: Department of Surgical and Medical Critical Care, Section of Neonatology, University of Florence
name: Carlo Dani, MD
role: PRINCIPAL_INVESTIGATOR
References: