Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877808
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2021-05-03
Brief Title:
Bacterial Surinfections in COVID-19 ICU Patients
Sponsor:
Jessa Hospital
Organization:
Jessa Hospital
Study Overview
Official Title:
Incidence and Predictive Value of Bacterial Surinfections on In-hospital Mortality in COVID-19 ICU Patients a Longitudinal Single-center Study
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bacteremiacatheter 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 183 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 bacteremiacatheter 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 bacteremiacatheter 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 ie 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 ie 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 PF ratio
Radiological findings pneumonia ground-glass opacity
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 bacteremiacatheter 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 bacteremiacatheter 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 ie 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 ie 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 PF ratio
Radiological findings pneumonia ground-glass opacity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None