Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412523
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2022-08-11
Brief Title:
Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
Sponsor:
Beneficência Portuguesa de São Paulo
Organization:
Beneficência Portuguesa de São Paulo
Study Overview
Official Title:
Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
IMPACTO-SNC
Brief Summary:
Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality In Brazil there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms however there is a lack of data related to central nervous system infections associated with invasive devices which can have a direct impact on prevention and treatment policies
Detailed Description:
Neurosurgical procedures with placement of devices are related to increased morbidity and mortality A study shows that the incidence of device-related central nervous system infection can reach 27 A meta-analysis published in 2015 which included 35 studies showed an incidence of 114 per 1000 catheters-day
This is a prospective cohort study including adult patients in the ICUs of hospitals participating in the IMPACTO MR Platform who have a catheter device for monitoring intracranial pressure or external ventricular shunt with infection densities and microbiological profile being evaluated risk factors clinical management costs involved and short- and long-term clinical outcomes
This is a prospective cohort study including adult patients in the ICUs of hospitals participating in the IMPACTO MR Platform who have a catheter device for monitoring intracranial pressure or external ventricular shunt with infection densities and microbiological profile being evaluated risk factors clinical management costs involved and short- and long-term clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None