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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06412523
Other study ID # 17558
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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