Clinical trial NCT06412549: Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Central Nervous System Infections
Keywords: Bacterial resistance
Health care
Central nervous systen infection
Multi-resistant microorganism
Lead sponsor: Beneficência Portuguesa de São Paulo
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2024-05-14
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the effect of the intervention bundle in ICUs on reducing central nervous system infections related to devices.
timeFrame: 30 days after study inclusion
Secondary outcomes:
measure: Microbiological profile identified in CSF culture results.
timeFrame: 30 days after study inclusion
measure: Risk factors
timeFrame: 30 days after study inclusion
measure: Drug treatment during hospital stay
timeFrame: 30 days after study inclusion
measure: Diagnostic accuracy
timeFrame: 30 days after study inclusion
measure: Cost of hospital admission in dollars, comparing patients with and without infection
timeFrame: 30 days after study inclusion
measure: Death rate
timeFrame: 30 days, 6 months and 1 year after study inclusion
measure: Rankin scale
timeFrame: 30 days, 6 months and 1 year after study inclusion
measure: Adherence of the study site to the intervention bundle
timeFrame: Monthly
Other outcomes:
Locations:
Study officials:
affiliation: BP - A Beneficência Portuguesa de São Paulo
name: Viviane Veiga, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Geral Clériston Andrade
name: Renata Oliveira
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Estadual do Cérebro Paulo Niemeyer
name: Cássia Shinotsuka
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas de Porto Alegre
name: Thiago Lisboa
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Amor de Barretos
name: Luciana Sanches
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Pelópidas Silveira
name: Lívia Medeiros
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Getúlio Vargas
name: Tássio Lavor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital da Restauração
name: Débora Pinho
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Pronto Socorro de Porto Alegre
name: Cristiano Franke
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitário Cajuru
name: Gabriela Teixeira
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitário Onofre Lopes
name: Eliane Silva
role: PRINCIPAL_INVESTIGATOR
affiliation: Hcor - Associação Beneficente Síria
name: Marcelo Romano
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clínicas de Ribeirão Preto
name: Wilson Lovato
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
name: Israel Maia
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Casa de Misericordia de Passos
name: Priscila Gonçalves
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Paulo
name: Flávia Machado
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Hospital de Base do Distrito Federal - IGESDF
name: Glécia Rocha
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clínicas FMUSP
name: Roberta Roepek
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.