Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00286104

Purpose

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	Intervention	Phase
Hydrocephalus Intracranial Hypertension	Device: Antibiotics-impregnated ventricular catheter (Bactiseal®) Device: Plain ventricular catheter (Codman EDS II/III)	Phase III

MedlinePlus related topics: Antibiotics High Blood Pressure Hydrocephalus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Impact of Ventricular Catheter Impregnated With Antimicrobial Agents on Infection in Patients With Ventricular Catheter: A Prospective Randomized Study

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Cerebrospinal fluid infection rate [ Time Frame: First 30 days ] [ Designated as safety issue: No ]
Extracranial infection rate [ Time Frame: First 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality rate [ Time Frame: At discharge and six months ] [ Designated as safety issue: Yes ]
Glasgow Outcome Scale Extended [ Time Frame: At discharge and at six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	April 2004
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated)	Device: Antibiotics-impregnated ventricular catheter (Bactiseal®) Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)
2: Placebo Comparator Plain ventricular catheter	Device: Plain ventricular catheter (Codman EDS II/III) Plain ventricular catheter

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286104

Contacts

Contact: George KC Wong, FRCSEd(SN)	+852 2632 2624	georgewong@surgery.cuhk.edu.hk
Contact: Wai S Poon, FRCS	+852 2632 2638	wpoon@surgery.cuhk.edu.hk

Locations

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

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:	George KC Wong, FRCSEd(SN)	Chinese University of Hong Kong
Study Director:	George KC Wong, FRCSEd(SN)	Chinese University of Hong Kong

More Information

No publications provided

Responsible Party:	Division of Neurosurgery, The Chinese University of Hong Kong ( George KC Wong )
Study ID Numbers:	CREC-PWS-002
Study First Received:	February 1, 2006
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00286104 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

Ventriculitis
External ventricular catheter
Antibiotic-impregnated

Study placed in the following topic categories:

Rifampin
Anti-Bacterial Agents
Clindamycin
Clindamycin-2-phosphate
Vascular Diseases
Pseudotumor Cerebri

Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Anti-Infective Agents
Nervous System Diseases
Pseudotumor Cerebri
Vascular Diseases
Central Nervous System Diseases
Brain Diseases
Pharmacologic Actions

Intracranial Hypertension
Anti-Bacterial Agents
Therapeutic Uses
Infant, Newborn, Diseases
Cardiovascular Diseases
Hydrocephalus
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009