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AgION Catheter for Preventing Catheter-Related Bloodstream Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564615
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Carlo Dani, 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.

Condition or disease Intervention/treatment Phase
Catheter-Related Infections Device: Umbilical catheterization (AgION ) Device: Umbilical catheterization (ArgyleTM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction of Catheter-Related Bloodstream Infections in Preterm Infants by the Use of Catheters With the AgION Antimicrobial System
Study Start Date : July 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: AgION catheter
Patients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Device: Umbilical catheterization (AgION )
Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).

Active Comparator: Non-impregnated polyurethane catheter
Patients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
Device: Umbilical catheterization (ArgyleTM)
Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564615


Locations
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Italy
Careggi Univesity Hospital
Florence, Italy, 50141
Sponsors and Collaborators
University of Florence
Investigators
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Principal Investigator: Carlo Dani, MD Department of Surgical and Medical Critical Care, Section of Neonatology, University of Florence
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Responsible Party: Carlo Dani, Associate Professor of Pediatrics, University of Florence
ClinicalTrials.gov Identifier: NCT01564615    
Other Study ID Numbers: 01/2012
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Keywords provided by Carlo Dani, University of Florence:
Catheter related bloodstream infection
Umbilical venous catheter
Silver
Preterm infants
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Catheter-Related Infections