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

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286104
• Other study ID #: CREC-PWS-002
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2006
• Last updated: December 21, 2009
• Start date: April 2004
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hydrocephalus
• Intracranial Hypertension

Intervention

Device:
• Antibiotics-impregnated ventricular catheter (Bactiseal®)
Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)
• Plain ventricular catheter (Codman EDS II/III)
Plain ventricular catheter

Locations

Country	Name	City	State
China	Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrospinal fluid infection rate		First 30 days	No
Primary	Extracranial infection rate		First 30 days	No
Secondary	Mortality rate		At discharge and six months	Yes
Secondary	Glasgow Outcome Scale Extended		At discharge and at six months	No