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

Central Nervous System Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412549
• Other study ID #: 6. NUP25000.1672362023-51
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Beneficência Portuguesa de São Paulo
• Contact: Viviane Veiga, Phd
• Phone: +55 11 99942-1721
• Email: viviane.veiga[@]bp.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1300
• Est. completion date: December 31, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System Infections

Intervention

Behavioral:
• Health 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beneficência Portuguesa de São Paulo	Ministry of Health, Brazil

References & Publications (5)

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 1:1-6. doi: 10.3171/2018.1.JNS172486. Online ahead of print. — View Citation

Jin 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. Erratum In: World J Surg. 2022 Jan;46(1):294. — View Citation

Karvouniaris 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. — View Citation

Lord 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. — View Citation

Ramanan 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days after study inclusion
Secondary	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.	30 days after study inclusion
Secondary	Risk factors	To compare microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not).	30 days after study inclusion
Secondary	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.	30 days after study inclusion
Secondary	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.	30 days after study inclusion
Secondary	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.	30 days after study inclusion
Secondary	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.	30 days, 6 months and 1 year 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; Compare rankin scale score before and after the intervention bundle.	30 days, 6 months and 1 year after study inclusion
Secondary	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.	Monthly