## Protocol Section
### Identification Module
**NCT ID:** NCT06412523

**Acronym:** IMPACTO-SNC

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 17558
#### Organization
**Class:** OTHER
**Full Name:** Beneficência Portuguesa de São Paulo
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-08-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-11
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beneficência Portuguesa de São Paulo

#### Responsible Party

**Investigator Affiliation:** Beneficência Portuguesa de São Paulo

**Investigator Full Name:** Viviane Cordeiro Veiga, MD, PhD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Central Nervous System Infections

**Keywords:**

- Central Nervous System Infections

- Catheters

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 554

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported.

**Measure:** Incidence density of central nervous system infection

**Time Frame:** 30 days after study inclusion

#### Secondary Outcomes

**Description:** Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not)

**Measure:** Microbiological characteristics

**Time Frame:** 30 days after study inclusion

**Description:** Risk factors for the development of central nervous system infections in the population studied: institution-associated, operator-associated, patient-associated

**Measure:** Risk factors

**Time Frame:** 30 days after study inclusion

**Description:** Treatment practices, focusing on: antimicrobials (time and duration) and focus management (device removal versus maintenance)

**Measure:** Treatment

**Time Frame:** 30 days after study inclusion

**Description:** Costs associated with the duration of infection

**Measure:** Costs

**Time Frame:** 30 days after study inclusion

**Description:** Deaths during hospital stay and long-term (6 months)

**Measure:** Deaths

**Time Frame:** 30 days and 6 months after study inclusion

**Description:** 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

**Measure:** Rankin scale

**Time Frame:** 30 days and 6 months after study inclusion

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adults admitted to Intensive Care Units.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Feira De Santana

**Country:** Brazil

**Facility:** Hospital Geral Cleriston Andrade

**State:** BA

**Location 2:**

**City:** Salvador

**Country:** Brazil

**Facility:** Hospital da Cidade

**State:** BA

**Location 3:**

**City:** Vitória

**Country:** Brazil

**Facility:** Unimed Vitória

**State:** ES

**Location 4:**

**City:** Belo Horizonte

**Country:** Brazil

**Facility:** Santa Casa de Belo Horizonte

**State:** MG

**Location 5:**

**City:** Passos

**Country:** Brazil

**Facility:** Santa Casa de Misericórdia de Passos

**State:** MG

**Location 6:**

**City:** São João Del Rei

**Country:** Brazil

**Facility:** Santa Casa de Misericórdia de São João del Rei

**State:** MG

**Location 7:**

**City:** Rio De Janeiro

**Country:** Brazil

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

**State:** RJ

**Location 8:**

**City:** Natal

**Country:** Brazil

**Facility:** Hospital Universitário Onofre Lopes

**State:** RN

**Location 9:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Hospital de Clinicas de Porto Alegre

**State:** RS

**Location 10:**

**City:** Florianópolis

**Country:** Brazil

**Facility:** Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck

**State:** SC

**Location 11:**

**City:** Barretos

**Country:** Brazil

**Facility:** Hospital de Amor (Fundação PIO XII - Barretos)

**State:** SP

**Location 12:**

**City:** Limeira

**Country:** Brazil

**Facility:** Hospital Unimed Limeira

**State:** SP

**Location 13:**

**City:** Ribeirão Preto

**Country:** Brazil

**Facility:** Hospital das Clínicas - FMUSP Ribeirão Preto

**State:** SP

**Location 14:**

**City:** Santo André

**Country:** Brazil

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

**State:** SP

**Location 15:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Beneficência Portuguesa de São Paulo

**State:** SP

**Location 16:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Hospital do Coração

**State:** SP

**Location 17:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Hospital São Luiz Itaim

**State:** SP

**Location 18:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Hospital São Paulo

**State:** SP

#### Overall Officials

**Official 1:**

**Affiliation:** Beneficencia Portuguesa Sao Paulo

**Name:** Viviane Veiga, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M5743

- Name: Central Nervous System Infections

- Relevance: HIGH

- As Found: Central Nervous System Infections

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000002494

- Term: Central Nervous System Infections

### Misc Info Module

- Version Holder: 2024-05-31
