Central Nervous System Infections
Conditions
Keywords
Bacterial resistance, Health care, Central nervous systen infection, Multi-resistant microorganism
Brief summary
Non-randomized clinical trial conducted in the adult ICUs of Brazilian hospitals participating in the IMPACTO MR Platform, involving adult patients using an intracranial pressure monitoring catheter device or external ventricular drain. The study will test the hypothesis that the intervention bundle, following ANVISA recommendations for care practices, will reduce the rates of central nervous system infections associated with ICP and EVD devices. This reduction is expected to lead to more accurate diagnoses, decreased antibiotic usage, shortened ICU and hospital stays, and reduced hospital costs.
Detailed description
IMPACTO MR is a research platform that originated as a prospective and collaborative observational study collecting clinical, microbiological, and cost data from patients admitted to Brazilian adult ICUs during the three-year periods 2018-2020 and 2021-2023. Data were collected from all adult patients admitted to the ICUs of at least 61 hospitals selected for the platform. This project aims to collect data from approximately 20 participating hospitals that perform neurosurgical procedures involving external ventricular drain catheter implantation and intracranial pressure monitoring, with the goal of establishing national data on the prevalence of these conditions. The first phase of the study will involve completing data collection for the prospective cohort conducted between 2022 and 2023. This cohort is part of the IMPACTO MR: Device-related central nervous system infections in adult intensive care units in Brazil - Action Plan Support Project Platform National Prevention and Control of Antimicrobial Resistance) with the same hospitals. This will represent the baseline incidence of central nervous system infections related to devices and care practices for patients with intracranial pressure monitoring catheters and external ventricular drains. The data will include information on risk factors, care processes, and clinical management in suspected central nervous system infections related to these devices. In the second phase of the study, an intervention bundle will be implemented to prevent infections and improve care processes in these ICUs progressively. Diagnostic site visits will be conducted at hospitals to support the construction of this intervention bundle, and all participating hospitals will receive continuous training to facilitate measurement of results. The intervention bundle will be based on ANVISA recommendations for controlling healthcare-associated infections. Currently, the recommendations are based on the care to be followed from pre-operative to post-operative stages, including the use of checklists with daily goals, recommendations for dressing care, catheter handling, and treatment in the presence of infection. The intervention bundle will be developed by a minimum team of doctors and nurses from the coordinating hospital. After conducting a situational diagnosis, this team will develop care protocols, checklists with daily goals, and training materials for the participating centers. Throughout the project, systematic feedback meetings will be held to monitor action plans, both remotely and, if necessary, in person. The intervention will be implemented within each hospital until the proposed sample size is attained.
Interventions
BEHAVIORALHealth care practices and routines
The scope of the project includes a diagnostic visit to participating hospitals, conducted by the coordinating center team, to understand existing protocols related to the management of invasive central nervous system devices (such as intracranial pressure monitoring catheters or external ventricular drains), as well as the physical infrastructure, human resources, and other precautions taken for the prevention and treatment of central nervous system infections. All recommendations in the intervention bundle for patient care will align with the guidelines of the National Health Surveillance Agency (ANVISA) and the best available scientific evidence for preventing infections associated with central nervous system devices. * Provide the best care for patients with ICP and/or EVD, based on the best available evidence, with regard to the insertion and maintenance of catheters, as well as diagnosis and treatment in the presence of infection. * Training of the multidisciplinary team.
Sponsors
Ministry of Health, Brazil
Beneficência Portuguesa de São Paulo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The first phase of the project included 554 participants (baseline sample) and the second phase included 746 participants (intervention sample). Totaling 1,300 patients with external ventricular drain and/or intracranial pressure monitoring catheter.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with intracranial pressure monitoring catheters (intraventricular or intraparenchymal) and/or external ventricular drain. * The patient can be included from the moment the catheter is implanted, without there being a minimum time for inclusion.
Exclusion criteria
* Suspected or confirmed brain death.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of the intervention bundle in ICUs on reducing central nervous system infections related to devices. | 30 days after study inclusion | To compare the incidence of device-related central nervous system infections at baseline and after the implementation of the intervention bundle. The percentage of suspected infection cases and those confirmed by ANVISA criteria will be compared at both study timepoints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological profile identified in CSF culture results. | 30 days after study inclusion | Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not) at baseline versus the group included after the intervention bundle. The outcome will be measured based on the positive liquor culture and antibiogram. |
| Risk factors | 30 days after study inclusion | To compare microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not). |
| Drug treatment during hospital stay | 30 days after study inclusion | To compare treatment practices for device-related central nervous system infections at baseline versus the group included after the intervention bundle. The outcome will be measured based on the antibiotic classes used to treat CNS infection, dose and time of use of antibiotics. The treatment data will be collected from the medical prescription during the hospital stay. |
| Cost of hospital admission in dollars, comparing patients with and without infection | 30 days after study inclusion | Compare costs associated with the duration of infection at baseline versus the group included after the intervention bundle. The outcome will be measured based on the demographic characteristics, Saps3, infection (yes or no), use of antibiotics and time of permanence on ICU. |
| Death rate | 30 days, 6 months and 1 year after study inclusion | The outcome will be measured based on the vital status on the hospital discharge, follow-up in 30 days, 6 months and 1 year. |
| Rankin scale | 30 days, 6 months and 1 year 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 * Dead Compare rankin scale score before and after the intervention bundle. |
| Adherence of the study site to the intervention bundle | Monthly | From the first patient enrollment at participating centers to the last hospital discharge of the recruited sample. |
| Diagnostic accuracy | 30 days after study inclusion | The difference between the percentages of suspected and confirmed infection cases at baseline will be evaluated, compared to the group included after the intervention bundle. |
Contacts
Primary ContactViviane Veiga, Phd
Backup ContactJuliana Coelho, Phd
Outcome results
None listed