Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00286104|
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : December 23, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus Intracranial Hypertension||Device: Antibiotics-impregnated ventricular catheter (Bactiseal®) Device: Plain ventricular catheter (Codman EDS II/III)||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Ventricular Catheter Impregnated With Antimicrobial Agents on Infection in Patients With Ventricular Catheter: A Prospective Randomized Study|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||June 2009|
Active Comparator: 1
Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated)
Device: Antibiotics-impregnated ventricular catheter (Bactiseal®)
Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)
Other Name: Bactiseal
Placebo Comparator: 2
Plain ventricular catheter
Device: Plain ventricular catheter (Codman EDS II/III)
Plain ventricular catheter
Other Name: Codman EDS II/III
- Cerebrospinal fluid infection rate [ Time Frame: First 30 days ]
- Extracranial infection rate [ Time Frame: First 30 days ]
- Mortality rate [ Time Frame: At discharge and six months ]
- Glasgow Outcome Scale Extended [ Time Frame: At discharge and at six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286104
|China, Hong Kong|
|Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong|
|Hong Kong, Hong Kong, China, 852|
|Principal Investigator:||George KC Wong, FRCSEd(SN)||Chinese University of Hong Kong|
|Study Director:||George KC Wong, FRCSEd(SN)||Chinese University of Hong Kong|