- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941092
Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU
July 8, 2022 updated by: Lev VOLKOV, Central Hospital, Nancy, France
Clinical Outcomes and Characteristics of Critically Ill Patients With Influenza and COVID-19 Induced ARDS: a Retrospective, Matched Cohort Study
Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus.
However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant.
Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
157
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nancy, France, 54000
- CHRU Nancy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
patients hospitalized in Intensive Care Unit Hopital Central, Regional University Hospital of Nancy, France
- hospitalized between 2009 and 2019 if influenza and in 2020 if SARS CoV 2
Description
Inclusion Criteria:
- patients hospitalized in ICU
- under mechanical ventilation
- presenting an ARDS according to the Berlin definition
- induced by either influenza or SARS CoV 2
Exclusion Criteria:
- pregnant women
- mechanical ventilation>48 hours before admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with ARDS induced by SARS CoV 2
|
no intervention, retrospective comparison
|
|
patients with ARDS induced by influenza
|
no intervention, retrospective comparison
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
mortality
Time Frame: at 28 days
|
at 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
length of stay in ICU
Time Frame: at 28 days
|
at 28 days
|
|
length of mechanical ventilation
Time Frame: at 28 days
|
at 28 days
|
|
length of vasopressors
Time Frame: at 28 days
|
at 28 days
|
|
length of extrarenal epuration
Time Frame: at 28 days
|
at 28 days
|
|
amount of drugs for sedation
Time Frame: at 28 days
|
at 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
July 10, 2021
Study Completion (Actual)
July 10, 2021
Study Registration Dates
First Submitted
June 24, 2021
First Submitted That Met QC Criteria
June 24, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2022
Last Update Submitted That Met QC Criteria
July 8, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Infant, Newborn, Diseases
- Orthomyxoviridae Infections
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Influenza, Human
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- 2021PI076
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.