Central Nervous System Infections Clinical Trial
— IMPACTO-SNCOfficial title:
Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
Verified date | May 2024 |
Source | Beneficência Portuguesa de São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 554 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Amor (Fundação PIO XII - Barretos) | Barretos | SP |
Brazil | Santa Casa de Belo Horizonte | Belo Horizonte | MG |
Brazil | Hospital Geral Cleriston Andrade | Feira De Santana | BA |
Brazil | Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck | Florianópolis | SC |
Brazil | Hospital Unimed Limeira | Limeira | SP |
Brazil | Hospital Universitário Onofre Lopes | Natal | RN |
Brazil | Santa Casa de Misericórdia de Passos | Passos | MG |
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | RS |
Brazil | Hospital das Clínicas - FMUSP Ribeirão Preto | Ribeirão Preto | SP |
Brazil | Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar) | Rio De Janeiro | RJ |
Brazil | Hospital da Cidade | Salvador | BA |
Brazil | Hospital e Maternidade Brasil (Rede D´or São Luis) | Santo André | SP |
Brazil | Santa Casa de Misericórdia de São João del Rei | São João Del Rei | MG |
Brazil | Beneficência Portuguesa de São Paulo | São Paulo | SP |
Brazil | Hospital do Coração | São Paulo | SP |
Brazil | Hospital São Luiz Itaim | São Paulo | SP |
Brazil | Hospital São Paulo | São Paulo | SP |
Brazil | Unimed Vitória | Vitória | ES |
Lead Sponsor | Collaborator |
---|---|
Beneficência Portuguesa de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence density of central nervous system infection | Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported. | 30 days after study inclusion | |
Secondary | Microbiological characteristics | Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not) | 30 days after study inclusion | |
Secondary | Risk factors | Risk factors for the development of central nervous system infections in the population studied: institution-associated, operator-associated, patient-associated | 30 days after study inclusion | |
Secondary | Treatment | Treatment practices, focusing on: antimicrobials (time and duration) and focus management (device removal versus maintenance) | 30 days after study inclusion | |
Secondary | Costs | Costs associated with the duration of infection | 30 days after study inclusion | |
Secondary | Deaths | Deaths during hospital stay and long-term (6 months) | 30 days and 6 months after study inclusion | |
Secondary | Rankin scale | 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 Dead |
30 days and 6 months after study inclusion |
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