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NCT Number: NCT06412549

Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health care practices and routines

Behavioral

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.

Primary outcomes

  1. To evaluate the effect of the intervention bundle in ICUs on reducing central nervous system infections related to devices.

    Time frame: 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 outcomes

  1. Microbiological profile identified in CSF culture results.

    Time frame: 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.

  2. Risk factors

    Time frame: 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).

  3. Drug treatment during hospital stay

    Time frame: 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.

  4. Diagnostic accuracy

    Time frame: 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.

  5. Cost of hospital admission in dollars, comparing patients with and without infection

    Time frame: 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.

  6. Death rate

    Time frame: 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.

  7. Rankin scale

    Time frame: 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.

  8. Adherence of the study site to the intervention bundle

    Time frame: Monthly

    From the first patient enrollment at participating centers to the last hospital discharge of the recruited sample.

Study contacts

Contact information is provided by the study sponsor or research team.

Juliana Coelho, Phd

CONTACT

[email protected]

+55 11 98971-5801

Viviane Veiga, Phd

CONTACT

[email protected]

+55 11 99942-1721

Sponsors and collaborators

Lead sponsor

Beneficência Portuguesa de São Paulo

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

IMPACTO MR: Effect of a Bundle of Interventions on Patients With Central Nervous System Devices - Project Platform Supporting the National Action Plan for Prevention and Control of Antimicrobial Resistance

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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