Clinical trial NCT06412523: Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
Official title: Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Central Nervous System Infections
Keywords: Central Nervous System Infections
Catheters
Lead sponsor: Beneficência Portuguesa de São Paulo
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults admitted to Intensive Care Units.

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

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.

Primary outcomes:
measure: Incidence density of central nervous system infection
timeFrame: 30 days after study inclusion
Secondary outcomes:
measure: Microbiological characteristics
timeFrame: 30 days after study inclusion
measure: Risk factors
timeFrame: 30 days after study inclusion
measure: Treatment
timeFrame: 30 days after study inclusion
measure: Costs
timeFrame: 30 days after study inclusion
measure: Deaths
timeFrame: 30 days and 6 months after study inclusion
measure: Rankin scale
timeFrame: 30 days and 6 months after study inclusion
Other outcomes:
Locations:
city: Feira De Santana
country: Brazil
facility: Hospital Geral Cleriston Andrade
state: BA
city: Salvador
country: Brazil
facility: Hospital da Cidade
state: BA
city: Vitória
country: Brazil
facility: Unimed Vitória
state: ES
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Belo Horizonte
state: MG
city: Passos
country: Brazil
facility: Santa Casa de Misericórdia de Passos
state: MG
city: São João Del Rei
country: Brazil
facility: Santa Casa de Misericórdia de São João del Rei
state: MG
city: Rio De Janeiro
country: Brazil
facility: Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar)
state: RJ
city: Natal
country: Brazil
facility: Hospital Universitário Onofre Lopes
state: RN
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Florianópolis
country: Brazil
facility: Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
state: SC
city: Barretos
country: Brazil
facility: Hospital de Amor (Fundação PIO XII - Barretos)
state: SP
city: Limeira
country: Brazil
facility: Hospital Unimed Limeira
state: SP
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas - FMUSP Ribeirão Preto
state: SP
city: Santo André
country: Brazil
facility: Hospital e Maternidade Brasil (Rede D´or São Luis)
state: SP
city: São Paulo
country: Brazil
facility: Beneficência Portuguesa de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
city: São Paulo
country: Brazil
facility: Hospital São Luiz Itaim
state: SP
city: São Paulo
country: Brazil
facility: Hospital São Paulo
state: SP
Study officials:
affiliation: Beneficencia Portuguesa Sao Paulo
name: Viviane Veiga, PhD
role: PRINCIPAL_INVESTIGATOR
References: