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

December 21, 2009 updated by: Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 852
        • Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated)
Device: Antibiotics-impregnated ventricular catheter (Bactiseal®)
Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)
Other Names:
  • Bactiseal
Placebo Comparator: 2
Plain ventricular catheter
Device: Plain ventricular catheter (Codman EDS II/III)
Plain ventricular catheter
Other Names:
  • Codman EDS II/III

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebrospinal fluid infection rate
Time Frame: First 30 days
First 30 days
Extracranial infection rate
Time Frame: First 30 days
First 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality rate
Time Frame: At discharge and six months
At discharge and six months
Glasgow Outcome Scale Extended
Time Frame: At discharge and at six months
At discharge and at six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: George KC Wong, FRCSEd(SN), Chinese University of Hong Kong
  • Study Director: George KC Wong, FRCSEd(SN), Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria

February 1, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 21, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC-PWS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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