Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04877808 |
| Other study ID # |
f2021/037 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2021 |
| Est. completion date |
August 15, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Jessa Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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..
