Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter

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Brief Title

Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter

Official Title

The Impact of Ventricular Catheter Impregnated With Antimicrobial Agents on Infection in Patients With Ventricular Catheter: A Prospective Randomized Study

Brief 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Cerebrospinal fluid infection rate

Secondary Outcome

 Mortality rate

Condition

Hydrocephalus

Intervention

Antibiotics-impregnated ventricular catheter (Bactiseal®)

Study Arms / Comparison Groups

 1
Description:  Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

184

Start Date

April 2004

Completion Date

June 2009

Primary Completion Date

December 2008

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with external ventricular drain inserted

          2. Patients with external ventricular drain in-situ planned for at least 5 days

        Exclusion Criteria:

          1. Known CSF infection including meningitis

          2. Known sepsis

          3. Uncorrected coagulopathy

          4. No consent available
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

George KC Wong, FRCSEd(SN), , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT00286104

Organization ID

CREC-PWS-002



Study Sponsor

Chinese University of Hong Kong


Study Sponsor

George KC Wong, FRCSEd(SN), Principal Investigator, Chinese University of Hong Kong


Verification Date

July 2009