Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
- Conditions
- Central Nervous System Infections
- Registration Number
- NCT06412523
- Lead Sponsor
- Beneficência Portuguesa de São Paulo
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 554
- 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.
- Diagnosis of brain death.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence density of central nervous system infection 30 days after study inclusion Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported.
- Secondary Outcome Measures
Name Time Method Deaths 30 days and 6 months after study inclusion Deaths during hospital stay and long-term (6 months)
Treatment 30 days after study inclusion Treatment practices, focusing on: antimicrobials (time and duration) and focus management (device removal versus maintenance)
Costs 30 days after study inclusion Costs associated with the duration of infection
Rankin scale 30 days and 6 months after study inclusion Measures 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
* DeadMicrobiological characteristics 30 days after study inclusion Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not)
Risk factors 30 days after study inclusion Risk factors for the development of central nervous system infections in the population studied: institution-associated, operator-associated, patient-associated
Trial Locations
- Locations (18)
Santa Casa de Belo Horizonte
🇧🇷Belo Horizonte, MG, Brazil
Hospital Geral Cleriston Andrade
🇧🇷Feira De Santana, BA, Brazil
Unimed Vitória
🇧🇷Vitória, ES, Brazil
Hospital da Cidade
🇧🇷Salvador, BA, Brazil
Santa Casa de Misericórdia de São João del Rei
🇧🇷São João Del Rei, MG, Brazil
Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar)
🇧🇷Rio De Janeiro, RJ, Brazil
Santa Casa de Misericórdia de Passos
🇧🇷Passos, MG, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Hospital Universitário Onofre Lopes
🇧🇷Natal, RN, Brazil
Hospital de Amor (Fundação PIO XII - Barretos)
🇧🇷Barretos, SP, Brazil
Hospital Unimed Limeira
🇧🇷Limeira, SP, Brazil
Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
🇧🇷Florianópolis, SC, Brazil
Hospital das Clínicas - FMUSP Ribeirão Preto
🇧🇷Ribeirão Preto, SP, Brazil
Hospital São Paulo
🇧🇷São Paulo, SP, Brazil
Beneficência Portuguesa de São Paulo
🇧🇷São Paulo, SP, Brazil
Hospital e Maternidade Brasil (Rede D´or São Luis)
🇧🇷Santo André, SP, Brazil
Hospital São Luiz Itaim
🇧🇷São Paulo, SP, Brazil
Hospital do Coração
🇧🇷São Paulo, SP, Brazil