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Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil

Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06412523
Acronym
IMPACTO-SNC
Enrollment
554
Registered
2024-05-14
Start date
2022-08-15
Completion date
2024-06-30
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Infections

Keywords

Central Nervous System Infections, Catheters

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 11.4 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

Interventions

None listed

Sponsors

Beneficência Portuguesa de São Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All patients over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt.

Exclusion criteria

* Diagnosis of brain death.

Design outcomes

Primary

MeasureTime frameDescription
Incidence density of central nervous system infection30 days after study inclusionIncidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported.

Secondary

MeasureTime frameDescription
Microbiological characteristics30 days after study inclusionMicrobiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not)
Risk factors30 days after study inclusionRisk factors for the development of central nervous system infections in the population studied: institution-associated, operator-associated, patient-associated
Treatment30 days after study inclusionTreatment practices, focusing on: antimicrobials (time and duration) and focus management (device removal versus maintenance)
Costs30 days after study inclusionCosts associated with the duration of infection
Deaths30 days and 6 months after study inclusionDeaths during hospital stay and long-term (6 months)
Rankin scale30 days and 6 months after study inclusionMeasures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The patient is classified as follows: * No symptoms at all; * No significant disability despite symptoms; able to carry out all usual duties and activities * Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance * Moderate disability; requiring some help, but able to walk without assistance * Moderately severe disability; unable to walk and attend to bodily needs without assistance * Severe disability; bedridden, incontinent and requiring constant nursing care and attention * Dead

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026