Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286104
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2006-02-01
Brief Title:
Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
The Impact of Ventricular Catheter Impregnated With Antimicrobial Agents on Infection in Patients With Ventricular Catheter A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 22 to 104 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 opportunisticnosocomial infections and improves the overall outcome in these patients that would convert into a reduction in treatment cost of these patients
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 opportunisticnosocomial 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 opportunisticnosocomial 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
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 opportunisticnosocomial 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None