Clinical trial NCT04877808: Bacterial Surinfections in COVID-19 ICU Patients
Official title: Incidence and Predictive Value of Bacterial Surinfections on In-hospital Mortality in COVID-19 ICU Patients: a Longitudinal Single-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult COVID-19 patients admitted to the ICU from 13th of March until 17th of October 2020 were included.

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..

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of sepsis
timeFrame: through study completion, 8 months
measure: Incidence of VAP
timeFrame: through study completion, 8 months
measure: Incidence of bacterial catheter infections
timeFrame: through study completion, 8 months
Secondary outcomes:
measure: Correlation with corticosteroids
timeFrame: through study completion, 8 months
measure: Correlation with the length of stay in ICU and hospital
timeFrame: through study completion, 8 months
measure: Correlation with venous thromboembolism
timeFrame: through study completion, 8 months
measure: Correlation with the number of bacterial episodes
timeFrame: through study completion, 8 months
measure: Correlation with the types
timeFrame: through study completion, 8 months
measure: Correlation with ICU mortality
timeFrame: through study completion, 8 months
measure: Correlation between presences of thrombi and bacteremia/catheter sepsis
timeFrame: through study completion, 8 months
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa hospital
Study officials:
References: