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Bacterial Surinfections in COVID-19 ICU Patients

Completed
Conditions
Covid19
Registration Number
NCT04877808
Lead Sponsor
Jessa Hospital
Brief Summary

The aim of this study is to assess the incidence of bacterial surinfections (sepsis, VAP and catheter infections) in COVID-19 patients admitted to the ICU from 13th of March 2020 until 17h of October 2020. In addition, the association of these infections with the dose of corticosteroids, the length of stay in ICU and in hospital, the presence of venous thromboembolism, the number of bacterial episodes, the different types of bacteria causing the infections and ICU mortality will be evaluated as well as the associations between the presences of thrombi and bacteremia/catheter sepsis.

Detailed Description

Approximately 5% of patients with respiratory impairment develop a severe form with acute respiratory failure and require specialized management in the Intensive Care Unit (ICU). Invasive mechanical ventilation (IVM) exposes ICU patients to a particular risk of a nosocomial infectious complication called ventilator-associated pneumonia (VAP). In Europe, the incidence density is 18.3 VAP per 1000 days of IMV.

The coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) emerged in December 2019 and has rapidly spread worldwide (Liu). The mortality of critical ill patients with COVID-19 has been reported variously as low as 11% and as high as 61% (Liu). Since March 2020, several thousand people have been receiving IMV due to severe COVID-19.

Informal exchanges between clinicians regarding the current pandemic indicate a high frequency of VAP. Several factors may account for a higher incidence of VAP in the population hospitalized in the ICU for SARS CoV-2 infection (Blonz 2021):

* A longer ventilation period, leading to greater mechanical exposure to the risk of VAP.

* The frequency of comorbidities.

* The frequency of ARDS, which is associated with a higher incidence of VAP.

* A form of acquired immunosuppression related to SARS-CoV-2 infection,

* Organizational factors related to the fact that this is the first major pandemic in modern history

Aim The aim of this study is to assess the incidence of bacterial surinfections (sepsis, VAP and catheter infections) in COVID-19 patients admitted to the ICU from 13th of March 2020 until 17h of October 2020. In addition, the association of these infections with the dose of corticosteroids, the length of stay in ICU and in hospital, the presence of venous thromboembolism, the number of bacterial episodes, the different types of bacteria causing the infections and ICU mortality will be evaluated as well as the associations between the presences of thrombi and bacteremia/catheter sepsis.

Design This is a retrospective, single-center study investigating the incidence of bacterial surinfections in COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020.

Inclusion criteria All adult COVID-19 patients admitted to the ICU from 13th of March until 17th of October 2020 were included.

Outcome measures The primary endpoint of this retrospective study is to assess the incidence of bacterial surinfections (sepsis, VAP and catheter infections) in COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020.

Secondary endpoints are the association of these infections with the dose of corticosteroids, the length of stay in ICU and in hospital, the presence of venous thromboembolism, the number of bacterial episodes, the different types of bacteria causing the infections and ICU mortality as well as the associations between the presences of thrombi and bacteremia/catheter sepsis in COVID-19 patients admitted to the ICU between 13th of March 2020 until 17th of October 2020.

Additional data collection

Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:

* Demographics: i.e age, gender, BMI

* DNR code

* Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), liver failure, gastrointestinal disease, neurological conditions, mental state, other

* Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc...

* Laboratory results of all standard parameters measured

* Treatment: antiviral agents, antibiotics, corticosteroids, etc...

* Complications: shock, heart failure, sepsis, stroke, bacteraemia, VAP, type of bacteria causing the infection, ... etc

* Ventilation: method, PEEP, FiO2, P/F ratio ..

* Radiological findings: pneumonia, ground-glass opacity..

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
116
Inclusion Criteria
  • All adult COVID-19 patients admitted to the ICU from 13th of March until 17th of October 2020 were included.
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of bacterial catheter infectionsthrough study completion, 8 months

Incidence of bacterial surinfections (catheter infections) in COVID-19 patients admitted to the ICU

Incidence of sepsisthrough study completion, 8 months

Incidence of bacterial surinfections (sepsis) in COVID-19 patients admitted to the ICU

Incidence of VAPthrough study completion, 8 months

Incidence of bacterial surinfections (VAP) in COVID-19 patients admitted to the ICU

Secondary Outcome Measures
NameTimeMethod
Correlation with venous thromboembolismthrough study completion, 8 months

Correlation of bacterial surinfections with the presence of venous thromboembolism

Correlation with corticosteroidsthrough study completion, 8 months

Correlation of bacterial surinfections with the dose of cortisosteroids

Correlation with the length of stay in ICU and hospitalthrough study completion, 8 months

Correlation of bacterial surinfections with the length of stay in ICU and hospital

Correlation with the number of bacterial episodesthrough study completion, 8 months

Correlation of bacterial surinfections with the number of bacterial episodes

Correlation with the typesthrough study completion, 8 months

Correlation with the different types of bacteria

Correlation with ICU mortalitythrough study completion, 8 months

Correlation of bacterial surinfections with the ICU mortality

Correlation between presences of thrombi and bacteremia/catheter sepsisthrough study completion, 8 months

Correlation between presences of thrombi and bacteremia/catheter sepsis

Trial Locations

Locations (1)

Jessa hospital

🇧🇪

Hasselt, Belgium

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