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Completed

NCT Number: NCT04877808

Bacterial Surinfections in COVID-19 ICU Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa hospital

Hasselt, 3500, Belgium

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of sepsis

    Time frame: through study completion, 8 months

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

  2. Incidence of VAP

    Time frame: through study completion, 8 months

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

  3. Incidence of bacterial catheter infections

    Time frame: through study completion, 8 months

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

Secondary outcomes

  1. Correlation with corticosteroids

    Time frame: through study completion, 8 months

    Correlation of bacterial surinfections with the dose of cortisosteroids

  2. Correlation with the length of stay in ICU and hospital

    Time frame: through study completion, 8 months

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

  3. Correlation with venous thromboembolism

    Time frame: through study completion, 8 months

    Correlation of bacterial surinfections with the presence of venous thromboembolism

  4. Correlation with the number of bacterial episodes

    Time frame: through study completion, 8 months

    Correlation of bacterial surinfections with the number of bacterial episodes

  5. Correlation with the types

    Time frame: through study completion, 8 months

    Correlation with the different types of bacteria

  6. Correlation with ICU mortality

    Time frame: through study completion, 8 months

    Correlation of bacterial surinfections with the ICU mortality

  7. Correlation between presences of thrombi and bacteremia/catheter sepsis

    Time frame: through study completion, 8 months

    Correlation between presences of thrombi and bacteremia/catheter sepsis

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 7, 2021
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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