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

Study Overview
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Brief Summary
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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
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Objective: To assess the cranial and extracranial infection rate of systemic antibiotic prophylaxis versus antibiotics-impregnated catheter. 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: Periprocedural antibiotics: Only ie Unasyn and Rocephin and insertion of the antibiotics-impregnated ventricular catheter. 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.

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

Conditions
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Hydrocephalus, Intracranial Hypertension

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with external ventricular drain inserted Patients with external ventricular drain in-situ planned for at least 5 days Exclusion Criteria: Known CSF infection including meningitis Known sepsis Uncorrected coagulopathy No consent available

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated) | Device: Antibiotics-impregnated ventricular catheter (Bactiseal®)<br>* Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)<br>* Other names: Bactiseal;|
| Placebo Comparator: 2<br>Plain ventricular catheter | Device: Plain ventricular catheter (Codman EDS II/III)<br>* Plain ventricular catheter<br>* Other names: Codman EDS II/III;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrospinal fluid infection rate |  | First 30 days | 
| Extracranial infection rate |  | First 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | At discharge and six months | 
| Glasgow Outcome Scale Extended |  | At discharge and at six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventriculitis, External ventricular catheter, Antibiotic-impregnated