Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil

NCT ID: NCT06412523

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 554 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2024-06-30

Brief Summary

Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. In Brazil, there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms, however, there is a lack of data related to central nervous system infections associated with invasive devices, which can have a direct impact on prevention and treatment policies.

Detailed Description

Neurosurgical procedures with placement of devices are related to increased morbidity and mortality. A study shows that the incidence of device-related central nervous system infection can reach 27%. A meta-analysis published in 2015, which included 35 studies, showed an incidence of 11.4 per 1000 catheters-day.

This is a prospective cohort study, including adult patients, in the ICUs of hospitals participating in the IMPACTO MR Platform, who have a catheter device for monitoring intracranial pressure or external ventricular shunt, with infection densities and microbiological profile being evaluated; risk factors; clinical management; costs involved and short- and long-term clinical outcomes

Conditions

Central Nervous System Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All patients 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 shunt.

Exclusion Criteria

• Diagnosis of brain death.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beneficência Portuguesa de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Viviane Cordeiro Veiga, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viviane Veiga, PhD

Role: PRINCIPAL_INVESTIGATOR

Beneficencia Portuguesa Sao Paulo

Locations

Unimed Vitória

Vitória, Espírito Santo, Brazil

Hospital Geral Cleriston Andrade

Feira de Santana, Estado de Bahia, Brazil

Hospital da Cidade

Salvador, Estado de Bahia, Brazil

Santa Casa de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, Brazil

Santa Casa de Misericórdia de São João del Rei

São João del Rei, Minas Gerais, Brazil

Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar)

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck

Florianópolis, Santa Catarina, Brazil

Hospital de Amor (Fundação PIO XII - Barretos)

Barretos, São Paulo, Brazil

Hospital Unimed Limeira

Limeira, São Paulo, Brazil

Hospital das Clínicas - FMUSP Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Hospital e Maternidade Brasil (Rede D´or São Luis)

Santo André, São Paulo, Brazil

Beneficência Portuguesa de São Paulo

São Paulo, São Paulo, Brazil

Hospital do Coração

São Paulo, São Paulo, Brazil

Hospital São Luiz Itaim

São Paulo, São Paulo, Brazil

Hospital São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

17558

Identifier Type: -

Identifier Source: org_study_id