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

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.

Study Overview

• Status: Completed
• Conditions: Covid19

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..

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of sepsis	Incidence of bacterial surinfections (sepsis) in COVID-19 patients admitted to the ICU	through study completion, 8 months
Incidence of VAP	Incidence of bacterial surinfections (VAP) in COVID-19 patients admitted to the ICU	through study completion, 8 months
Incidence of bacterial catheter infections	Incidence of bacterial surinfections (catheter infections) in COVID-19 patients admitted to the ICU	through study completion, 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with corticosteroids	Correlation of bacterial surinfections with the dose of cortisosteroids	through study completion, 8 months
Correlation with the length of stay in ICU and hospital	Correlation of bacterial surinfections with the length of stay in ICU and hospital	through study completion, 8 months
Correlation with venous thromboembolism	Correlation of bacterial surinfections with the presence of venous thromboembolism	through study completion, 8 months
Correlation with the number of bacterial episodes	Correlation of bacterial surinfections with the number of bacterial episodes	through study completion, 8 months
Correlation with the types	Correlation with the different types of bacteria	through study completion, 8 months
Correlation with ICU mortality	Correlation of bacterial surinfections with the ICU mortality	through study completion, 8 months
Correlation between presences of thrombi and bacteremia/catheter sepsis	Correlation between presences of thrombi and bacteremia/catheter sepsis	through study completion, 8 months

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: f2021/037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: None sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No