Prevention of Catheter-Related Bloodstream Infection in Patients With Hemato-Oncological Disease
Condition: Infection
MeSH terms: Infections; Communicable Diseases; Sepsis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this prospective randomised controlled trial is to compare the incidence of
      catheter-related bloodstream infection in 2 groups of patients with hemato-oncological
      disease:

      Group A: heparin-coated central venous catheters (Control Group) Group B: antiseptic-coated
      (chlorhexidine-silver sulfadiazine) central venous catheters
    

Detailed description: 
      Central venous lines (CVLs) are commonly used in patients with hemato-oncological disease for
      indications such as monitoring of hemodynamics and administration of blood products,
      chemotherapy, parenteral nutrition, and infusion fluids. Complications of catheterization
      include mechanical (arterial puncture, pneumothorax), thrombotic and infectious
      complications.Data from the National Nosocomial Infections Surveillance system (US) between
      January 1992 and February 1998 showed that catheter-related bloodstream infection (CRBI) is
      the third most frequent nosocomial infection and accounts for 14% of all nosocomial
      infections. CRBIs prolong hospital stays from 7 to 21 days and account for an estimated
      increase in hospital costs of $ 3000-40 000 per patient.In addition, an estimated 10-20%
      attributable mortality owing to nosocomial CRBI has been reported.

      Besides the aseptic measures both for the insertion of the catheter and its maintenance, many
      different approaches have been attempted to decrease central venous catheter infections:
      heparin-coated catheters, as well as antimicrobial and antiseptic impregnated CVLs.

      Heparin-coated catheters:

      Studies have shown that catheter-related infection may be due to fibrin deposition associated
      with catheters. Interventions designed to decrease fibrin deposition and thrombus formation
      have the potential to reduce catheter-related infections.

      Antiseptic-coated catheters:

      Catheter colonization is an essential prerequisite in the pathogenesis of CRBI. Colonization
      results from contamination of the catheters during insertion and subsequent care. There are
      data to suggest that contamination often occurs at the time of insertion. Therefore, attempts
      to prevent colonization focus on the elimination of initial contamination through aseptic
      technique and on the retardation of subsequent migration of organisms into the bloodstream.

      Recently, catheters impregnated with chlorhexidine and silver sulfadiazine have been
      developed to reduce the risk of catheter-related sepsis. Initial studies on humans showed
      that such impregnation could effectively reduce colonization in short-term catheterisation,
      but they have been less conclusive in showing the benefit of such impregnation in reducing
      catheter-related bloodstream infections.The efficacy of these antiseptic catheters varies in
      different subgroup populations.
    

Intervention name(s): Antiseptic-coated central venous catheters
Intervention type(s): Device
Intervention MeSH terms: Anti-Infective Agents, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Central venous catheter; Catheter related bloodstream infection; Heparin; Chlorhexidine; Sulfadiazine