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

NCT06412549 | Not Yet Recruiting

• 1 other identifier: 6. NUP25000.1672362023-51
• Study Type: interventional
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Nervous System Infections

Keywords

Bacterial resistance; Health care; Central nervous systen infection; Multi-resistant microorganism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Microbiological profile identified in CSF culture results.

  30 days after study inclusion

• Risk factors

  30 days after study inclusion

• Drug treatment during hospital stay

  30 days after study inclusion

• Diagnostic accuracy

  30 days after study inclusion

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

  30 days after study inclusion

Study Arms (2)

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

Behavioral: Health care practices and routines

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with intracranial pressure monitoring catheters (intraventricular or intraparenchymal) and/or external ventricular drain.

You may not qualify if:

• Suspected or confirmed brain death.

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo: lead
• Ministry of Health, Brazil: collaborator

Related 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 22;130(6):2034-2039. doi: 10.3171/2018.1.JNS172486. Print 2019 Jun 1.

  PMID: 29932377 BACKGROUND

• 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.

  PMID: 25567583 BACKGROUND

• 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.

  PMID: 34218314 BACKGROUND

• 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.

  PMID: 29998427 BACKGROUND

• 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.

  PMID: 35250284 BACKGROUND

MeSH Terms

Conditions

Central Nervous System Infections

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Viviane Veiga, Phd

  BP - A Beneficência 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 Universitário 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 São Paulo

  PRINCIPAL INVESTIGATOR

• Glécia Rocha

  Instituto Hospital de Base do Distrito Federal - IGESDF

  PRINCIPAL INVESTIGATOR

• Roberta Roepek

  Hospital das Clínicas FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviane Veiga, Phd

CONTACT

+55 11 99942-1721; viviane.veiga@bp.org.br

Juliana Coelho, Phd

CONTACT

+55 11 98971-5801; juliana.coelho@bp.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 14, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share