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Bacterial Surinfections in COVID-19 ICU Patients

Incidence and Predictive Value of Bacterial Surinfections on In-hospital Mortality in COVID-19 ICU Patients: a Longitudinal Single-center Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04877808
Enrollment
116
Registered
2021-05-07
Start date
2021-08-15
Completion date
2021-08-15
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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..

Interventions

None listed

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of sepsisthrough study completion, 8 monthsIncidence of bacterial surinfections (sepsis) in COVID-19 patients admitted to the ICU
Incidence of VAPthrough study completion, 8 monthsIncidence of bacterial surinfections (VAP) in COVID-19 patients admitted to the ICU
Incidence of bacterial catheter infectionsthrough study completion, 8 monthsIncidence of bacterial surinfections (catheter infections) in COVID-19 patients admitted to the ICU

Secondary

MeasureTime frameDescription
Correlation with the number of bacterial episodesthrough study completion, 8 monthsCorrelation of bacterial surinfections with the number of bacterial episodes
Correlation with the typesthrough study completion, 8 monthsCorrelation with the different types of bacteria
Correlation with corticosteroidsthrough study completion, 8 monthsCorrelation of bacterial surinfections with the dose of cortisosteroids
Correlation between presences of thrombi and bacteremia/catheter sepsisthrough study completion, 8 monthsCorrelation between presences of thrombi and bacteremia/catheter sepsis
Correlation with ICU mortalitythrough study completion, 8 monthsCorrelation of bacterial surinfections with the ICU mortality
Correlation with the length of stay in ICU and hospitalthrough study completion, 8 monthsCorrelation of bacterial surinfections with the length of stay in ICU and hospital
Correlation with venous thromboembolismthrough study completion, 8 monthsCorrelation of bacterial surinfections with the presence of venous thromboembolism

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026