Central Nervous System InfectionsNCT06412549
Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD)
A study testing Health care practices and routines in people with Central Nervous System Infections, run by Beneficência Portuguesa de São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Infections
- What is being tested?
- Health care practices and routines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Suspected or confirmed brain death.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Central Nervous System Infections
- Being tested
- Health care practices and routines
- Keywords
- Bacterial resistance, Health care, Central nervous systen infection, Multi-resistant microorganism
- Medical subject headings
- Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health care practices and routinesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Participants 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 drain. Baseline database obtained from the study "Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil (IMPACTO-SNC)", Carried out during the period from 2022 to 2023. |
| Intervention | Experimental | Participants over 18 years old admitted to the ICU in the selected hospitals and trained in the intervention bundle during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt. Participants included in the period from 2024 to 2026 Receives: Behavioral: Health care practices and routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of the intervention bundle in ICUs on reducing central nervous system infections related to devices.
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.
Measured: 30 days after study inclusion
Secondary outcomes (8)
Microbiological profile identified in CSF culture results.
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.
Measured: 30 days after study inclusion
Risk factors
To compare microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not).
Measured: 30 days after study inclusion
Drug treatment during hospital stay
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.
Measured: 30 days after study inclusion
Diagnostic accuracy
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.
Measured: 30 days after study inclusion
Cost of hospital admission in dollars, comparing patients with and without infection
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.
Measured: 30 days after study inclusion
Death rate
The outcome will be measured based on the vital status on the hospital discharge, follow-up in 30 days, 6 months and 1 year.
Measured: 30 days, 6 months and 1 year after study inclusion
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
Compare rankin scale score before and after the intervention bundle.
Measured: 30 days, 6 months and 1 year after study inclusion
Adherence of the study site to the intervention bundle
From the first patient enrollment at participating centers to the last hospital discharge of the recruited sample.
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beneficência Portuguesa de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, Viviane Cordeiro Veiga, MD, PhD, Beneficência Portuguesa de São Paulo
- Investigators
- Viviane Veiga, Phd, Principal investigator, Beneficência Portuguesa de São PauloRenata Oliveira, Principal investigator, Hospital Geral Clériston AndradeCássia Shinotsuka, Principal investigator, Instituto Estadual do Cérebro Paulo NiemeyerThiago Lisboa, Principal investigator, Hospital de Clinicas de Porto AlegreLuciana Sanches, Principal investigator, Hospital do Amor de BarretosLívia Medeiros, Principal investigator, Hospital Pelópidas SilveiraTássio Lavor, Principal investigator, Hospital Getúlio VargasDébora Pinho, Principal investigator, Hospital da Restauração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412549
- Sponsor's protocol ID
- 6. NUP25000.1672362023-51
- Status last verified
- May 2024
- First submitted
- 16 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Champey J, Mourey C, Francony G, Pavese P, Gay E, Gergele L, Manet R, Velly L, Bruder N, Payen JF. Strategies to reduce external ventricular drain-related infections: a multicenter retrospective study. J Neurosurg. 2018 Jun 22;130(6):2034-2039. doi: 10.3171/2018.1.JNS172486. Print 2019 Jun 1.
PubMed 29932377Ramanan M, Lipman J, Shorr A, Shankar A. A meta-analysis of ventriculostomy-associated cerebrospinal fluid infections. BMC Infect Dis. 2015 Jan 8;15:3. doi: 10.1186/s12879-014-0712-z.
PubMed 25567583Jin J, Akau Ola S, Yip CH, Nthumba P, Ameh EA, de Jonge S, Mehes M, Waiqanabete HI, Henry J, Hill A; International Society of Surgery (ISS) and the G4 Alliance International Standards and Guidelines for Quality Safe Surgery and Anesthesia (ISG-QSSA) Group. The Impact of Quality Improvement Interventions in Improving Surgical Infections and Mortality in Low and Middle-Income Countries: A Systematic Review and Meta-Analysis. World J Surg. 2021 Oct;45(10):2993-3006. doi: 10.1007/s00268-021-06208-y. Epub 2021 Jul 3.
PubMed 34218314Lord AS, Nicholson J, Lewis A. Infection Prevention in the Neurointensive Care Unit: A Systematic Review. Neurocrit Care. 2019 Aug;31(1):196-210. doi: 10.1007/s12028-018-0568-y.
PubMed 29998427Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.
PubMed 35250284
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06412549
- Acronym / sponsor ID
- 6. NUP25000.1672362023-51
- Conditions
- Central Nervous System Infections
- Keywords
- Bacterial resistance, Health care, Central nervous systen infection, Multi-resistant microorganism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Beneficência Portuguesa de São PauloUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Participants 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 drain. Baseline database obtained from the study "Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil (IMPACTO-SNC)", Carried out during the period from 2022 to 2023. |
| Intervention | Experimental | Behavioral: Health care practices and routinesParticipants over 18 years old admitted to the ICU in the selected hospitals and trained in the intervention bundle during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt. Participants included in the period from 2024 to 2026 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Suspected or confirmed brain death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health care practices and routinesThe 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. | Behavioural | Intervention |
Primary outcome
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.
8 secondary outcomes
Microbiological profile identified in CSF culture results.
Time frame: 30 days after study inclusion
Risk factors
Time frame: 30 days after study inclusion
Drug treatment during hospital stay
Time frame: 30 days after study inclusion
Diagnostic accuracy
Time frame: 30 days after study inclusion
Cost of hospital admission in dollars, comparing patients with and without infection
Time frame: 30 days after study inclusion
Death rate
Time frame: 30 days, 6 months and 1 year after study inclusion
Rankin scale
Time frame: 30 days, 6 months and 1 year after study inclusion
Adherence of the study site to the intervention bundle
Time frame: Monthly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 29932377Champey J, Mourey C, Francony G, Pavese P, Gay E, Gergele L, Manet R, Velly L, Bruder N, Payen JF. Strategies to reduce external ventricular drain-related infections: a multicenter retrospective study. J Neurosurg. 2018 Jun 22;130(6):2034-2039. doi: 10.3171/2018.1.JNS172486. Print 2019 Jun 1.
- Background: PubMed 25567583Ramanan M, Lipman J, Shorr A, Shankar A. A meta-analysis of ventriculostomy-associated cerebrospinal fluid infections. BMC Infect Dis. 2015 Jan 8;15:3. doi: 10.1186/s12879-014-0712-z.
- Background: PubMed 34218314Jin J, Akau Ola S, Yip CH, Nthumba P, Ameh EA, de Jonge S, Mehes M, Waiqanabete HI, Henry J, Hill A; International Society of Surgery (ISS) and the G4 Alliance International Standards and Guidelines for Quality Safe Surgery and Anesthesia (ISG-QSSA) Group. The Impact of Quality Improvement Interventions in Improving Surgical Infections and Mortality in Low and Middle-Income Countries: A Systematic Review and Meta-Analysis. World J Surg. 2021 Oct;45(10):2993-3006. doi: 10.1007/s00268-021-06208-y. Epub 2021 Jul 3.
- Background: PubMed 29998427Lord AS, Nicholson J, Lewis A. Infection Prevention in the Neurointensive Care Unit: A Systematic Review. Neurocrit Care. 2019 Aug;31(1):196-210. doi: 10.1007/s12028-018-0568-y.
- Background: PubMed 35250284Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viviane Veiga, Phd principal investigator
Beneficência Portuguesa de São Paulo
Renata Oliveira principal investigator
Hospital Geral Clériston Andrade
Cássia Shinotsuka principal investigator
Instituto Estadual do Cérebro Paulo Niemeyer
Questions about this trial
What is this clinical trial studying?
A study testing Health care practices and routines in people with Central Nervous System Infections, run by Beneficência Portuguesa de São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane Veiga, Phd (+55 11 99942-1721, viviane.veiga@bp.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412549, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.