AgION Catheter for Preventing Catheter-Related Bloodstream Infections
Condition: Catheter-Related Infections
MeSH terms: Infections; Communicable Diseases; Sepsis; Catheter-Related Infections
Study type: Interventional

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.
    

Intervention name(s): Umbilical catheterization (AgION ); Umbilical catheterization (ArgyleTM)
Intervention type(s): Device; Device
Intervention description(s): Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).; Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Catheter related bloodstream infection; Umbilical venous catheter; Silver; Preterm infants