Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter
Condition: Hydrocephalus; Intracranial Hypertension
MeSH terms: Hydrocephalus; Intracranial Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      External ventricular catheters are used for intracranial pressure monitoring and temporary
      cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related
      cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent
      literature. Previous prospective studies in the investigators' unit have shown that the use
      of dual antibiotics prophylaxis in patients with external ventricular drain was associated
      with decreased incidence of CSF infection but was complicated with opportunistic extracranial
      infections. The current practice is to cover with prophylactic dual antibiotics unless guided
      by microbiology results for all patients with external ventricular drain. In recent years,
      cerebrospinal fluid shunt catheters impregnated with antimicrobial agents have been
      available. Experimental studies have shown that they provide protection against
      staphylococcal aureus and coagulase-negative staphylococci strains for between 42 days and 56
      days. Theoretically, they provide the antibiotic prophylaxis locally without the associated
      complications of systemic antibiotics.

      It is hypothesized that the use of antibiotic-impregnated catheters instead of systemic
      antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will
      decrease the rate of opportunistic/nosocomial infections and improves the overall outcome in
      these patients; that would convert into a reduction in treatment cost of these patients.
    

Detailed description: 
      Objective:

        1. To assess the cranial and extracranial infection rate of systemic antibiotic prophylaxis
           versus antibiotics-impregnated catheter.

        2. To assess the patients' outcome and carry out cost analysis for systemic antibiotic
           prophylaxis versus antibiotics-impregnated catheter.

      Design: Prospective randomized controlled trial

      Hypothesis: The use of antibiotics-impregnated catheter instead of systemic antibiotic
      prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the
      rate of opportunistic/nosocomial infection and improves the overall outcome in these
      patients; that would convert into a reduction in treatment cost of these patients.

      Method: After ventricular catheter insertion, patients will be randomized into one of the two
      groups:

        1. Periprocedural antibiotics: Only ie Unasyn and Rocephin and insertion of the
           antibiotics-impregnated ventricular catheter.

        2. Periprocedural antibiotics and prophylactic dual antibiotics ie Unasyn and Rocephin and
           insertion of ventricular catheter without impregnation of antibiotics.

      Primary outcome variable: Cerebrospinal fluid infection and extracranial infection.

      Sample size: We aim to recruit a total of 180 patients with 90 patients in each arm and
      expect to complete patient recruitment in 2-3 years. The calculation is based to detect a
      difference of nosocomial infection rate between 20% and 40%, with 5% level of significance
      and 80% power.

      Projected results and significance:

      The project has a good chance to be the first clinical study to the outcome and cost impacts
      of antibiotic-impregnated ventricular catheter.
    

Intervention name(s): Antibiotics-impregnated ventricular catheter (Bactiseal®); Plain ventricular catheter (Codman EDS II/III)
Intervention type(s): Device; Device
Intervention description(s): Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated); Plain ventricular catheter
Other intervention name(s): Bactiseal; Codman EDS II/III
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ventriculitis; External ventricular catheter; Antibiotic-impregnated