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

Central Nervous System Infections Clinical Trial

— IMPACTO-SNC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06412523
• Other study ID #: 17558
• Status: Active, not recruiting
• Start date: August 15, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Beneficência Portuguesa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 554
• Est. completion date: June 30, 2024
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System Infections
• Communicable Diseases
• Infections

Locations

Country	Name	City	State
Brazil	Hospital de Amor (Fundação PIO XII - Barretos)	Barretos	SP
Brazil	Santa Casa de Belo Horizonte	Belo Horizonte	MG
Brazil	Hospital Geral Cleriston Andrade	Feira De Santana	BA
Brazil	Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck	Florianópolis	SC
Brazil	Hospital Unimed Limeira	Limeira	SP
Brazil	Hospital Universitário Onofre Lopes	Natal	RN
Brazil	Santa Casa de Misericórdia de Passos	Passos	MG
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital das Clínicas - FMUSP Ribeirão Preto	Ribeirão Preto	SP
Brazil	Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar)	Rio De Janeiro	RJ
Brazil	Hospital da Cidade	Salvador	BA
Brazil	Hospital e Maternidade Brasil (Rede D´or São Luis)	Santo André	SP
Brazil	Santa Casa de Misericórdia de São João del Rei	São João Del Rei	MG
Brazil	Beneficência Portuguesa de São Paulo	São Paulo	SP
Brazil	Hospital do Coração	São Paulo	SP
Brazil	Hospital São Luiz Itaim	São Paulo	SP
Brazil	Hospital São Paulo	São Paulo	SP
Brazil	Unimed Vitória	Vitória	ES

Sponsors (1)

Lead Sponsor	Collaborator
Beneficência Portuguesa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence density of central nervous system infection	Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported.	30 days after study inclusion
Secondary	Microbiological characteristics	Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not)	30 days after study inclusion
Secondary	Risk factors	Risk factors for the development of central nervous system infections in the population studied: institution-associated, operator-associated, patient-associated	30 days after study inclusion
Secondary	Treatment	Treatment practices, focusing on: antimicrobials (time and duration) and focus management (device removal versus maintenance)	30 days after study inclusion
Secondary	Costs	Costs associated with the duration of infection	30 days after study inclusion
Secondary	Deaths	Deaths during hospital stay and long-term (6 months)	30 days and 6 months 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	30 days and 6 months after study inclusion