AgION Catheter for Preventing Catheter-Related Bloodstream Infections
NCT ID: NCT01564615
Last Updated: 2012-03-28
Study Results
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Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2007-07-31
2009-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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AgION catheter
Patients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Umbilical catheterization (AgION )
Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Non-impregnated polyurethane catheter
Patients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
Umbilical catheterization (ArgyleTM)
Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Need of an umbilical venous catheter in the first week of life
* Parental informed consent.
Exclusion Criteria
* Hydrops fetalis
* Inherited congenital metabolic diseases
* Death during the first week of life
1 Day
7 Days
ALL
No
Sponsors
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University of Florence
OTHER
Responsible Party
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Carlo Dani
Associate Professor of Pediatrics
Principal Investigators
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Carlo Dani, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgical and Medical Critical Care, Section of Neonatology, University of Florence
Locations
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Careggi Univesity Hospital
Florence, Italy, Italy
Countries
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Other Identifiers
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01/2012
Identifier Type: -
Identifier Source: org_study_id
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