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

Condition(s) targeted: Hydrocephalus; Intracranial Hypertension

Intervention: Antibiotics-impregnated ventricular catheter (Bactiseal®) (Device); Plain ventricular catheter (Codman EDS II/III) (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Chinese University of Hong Kong

Official(s) and/or principal investigator(s):
George KC Wong, FRCSEd(SN), Principal Investigator, Affiliation: Chinese University of Hong Kong
George KC Wong, FRCSEd(SN), Study Director, Affiliation: Chinese University of Hong Kong

Overall contact:
George KC Wong, FRCSEd(SN), Phone: +852 2632 2624, Email: georgewong@surgery.cuhk.edu.hk

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.

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

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Cerebrospinal fluid infection rate

Extracranial infection rate

Secondary outcome:

Mortality rate

Glasgow Outcome Scale Extended

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

George KC Wong, FRCSEd(SN), Phone: +852 2632 2624, Email: georgewong@surgery.cuhk.edu.hk

Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong 852, China; Recruiting
George KC Wong, Phone: 852 26322624
Wai S Poon, FRCS, Sub-Investigator
George KC Wong, FRCSEd(SN), Principal Investigator
Margaret Ip, FRCPA, Sub-Investigator

Starting date: April 2004
Ending date: October 2009
Last updated: July 31, 2008