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

NCT ID: NCT00286104

Last Updated: 2009-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2009-06-30

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.

Conditions

Hydrocephalus; Intracranial Hypertension

Keywords

Ventriculitis; External ventricular catheter; Antibiotic-impregnated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated)

Group Type: ACTIVE_COMPARATOR

Antibiotics-impregnated ventricular catheter (Bactiseal®)

Intervention Type: DEVICE

Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)

2

Plain ventricular catheter

Group Type: PLACEBO_COMPARATOR

Plain ventricular catheter (Codman EDS II/III)

Intervention Type: DEVICE

Plain ventricular catheter

Interventions

Antibiotics-impregnated ventricular catheter (Bactiseal®)

Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)

Intervention Type: DEVICE

Plain ventricular catheter (Codman EDS II/III)

Plain ventricular catheter

Intervention Type: DEVICE

Other Intervention Names

Bactiseal; Codman EDS II/III

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Division of Neurosurgery, The Chinese University of Hong Kong

Principal Investigators

George KC Wong, FRCSEd(SN)

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

George KC Wong, FRCSEd(SN)

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Locations

Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 20466698 (View on PubMed)

Other Identifiers

CREC-PWS-002

Identifier Type: -

Identifier Source: org_study_id