Clinical trial NCT00286104: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hydrocephalus
Intracranial Hypertension
Keywords: Ventriculitis
External ventricular catheter
Antibiotic-impregnated
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Cerebrospinal fluid infection rate
timeFrame: First 30 days
measure: Extracranial infection rate
timeFrame: First 30 days
Secondary outcomes:
measure: Mortality rate
timeFrame: At discharge and six months
measure: Glasgow Outcome Scale Extended
timeFrame: At discharge and at six months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: George KC Wong, FRCSEd(SN)
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: George KC Wong, FRCSEd(SN)
role: STUDY_DIRECTOR
References:
citation: Wong GK, Ip M, Poon WS, Mak CW, Ng RY. Antibiotics-impregnated ventricular catheter versus systemic antibiotics for prevention of nosocomial CSF and non-CSF infections: a prospective randomised clinical trial. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1064-7. doi: 10.1136/jnnp.2009.198523. Epub 2010 May 12.