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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Central Nervous System Infections
• Intervention / Treatment: Behavioral: Health care practices and routines

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 Type: Interventional
• Enrollment (Estimated): 1300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viviane Veiga, Phd; Phone Number: +55 11 99942-1721; Email: viviane.veiga@bp.org.br
• Study Contact Backup: Name: Juliana Coelho, Phd; Phone Number: +55 11 98971-5801; Email: juliana.coelho@bp.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline; 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.
Experimental: Intervention; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Beneficência Portuguesa de São Paulo
• Collaborators: Ministry of Health, Brazil
• Investigators: Principal Investigator: Viviane Veiga, Phd, BP - A Beneficencia Portuguesa de São Paulo; Principal Investigator: Renata Oliveira, Hospital Geral Clériston Andrade; Principal Investigator: Cássia Shinotsuka, Instituto Estadual do Cérebro Paulo Niemeyer; Principal Investigator: Thiago Lisboa, Hospital de Clinicas de Porto Alegre; Principal Investigator: Luciana Sanches, Hospital do Amor de Barretos; Principal Investigator: Lívia Medeiros, Hospital Pelópidas Silveira; Principal Investigator: Tássio Lavor, Hospital Getúlio Vargas; Principal Investigator: Débora Pinho, Hospital da Restauração; Principal Investigator: Cristiano Franke, Hospital de Pronto Socorro de Porto Alegre; Principal Investigator: Gabriela Teixeira, Hospital Universitario Cajuru; Principal Investigator: Eliane Silva, Hospital Universitário Onofre Lopes; Principal Investigator: Marcelo Romano, Hcor - Associação Beneficente Síria; Principal Investigator: Wilson Lovato, Hospital das Clínicas de Ribeirão Preto; Principal Investigator: Israel Maia, Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck; Principal Investigator: Priscila Gonçalves, Santa Casa de Misericordia de Passos; Principal Investigator: Flávia Machado, Hospital Sao Paulo; Principal Investigator: Glécia Rocha, Instituto Hospital de Base do Distrito Federal - IGESDF; Principal Investigator: Roberta Roepek, Hospital das Clinicas FMUSP

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Health care; Bacterial resistance; Central nervous systen infection; Multi-resistant microorganism
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections
• Other Study ID Numbers: 6. NUP25000.1672362023-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No