Obesity and Mortality of Critically Ill Patients With COVID-19 (COV-OB-ICU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04425213|
Recruitment Status : Completed
First Posted : June 11, 2020
Last Update Posted : June 16, 2020
Disproportionate impact of COVID-19 in patients with obesity is now well established.
Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.
The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.
|Condition or disease|
|COVID Severe Acute Respiratory Syndrome Obesity Comorbidities and Coexisting Conditions|
The investigators aim to report ICU mortality for patients according to BMI category and to describe the detailed ICU clinical course of illness :
- Risk factors for ICU mortality : age, sex, baseline comorbidities
- Causes of death
- Risk factors for use of non invasive mechanical ventilation
- Non-fatal outcomes
- Ventilator-free days
- ICU length of stay.
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France|
|Actual Study Start Date :||May 12, 2020|
|Actual Primary Completion Date :||May 25, 2020|
|Actual Study Completion Date :||May 26, 2020|
BMI < 25 kg/m2
BMI : 25 - 29.9 kg/m2
BMI : 30 - 39.9 kg/m2
BMI : > or = 40 kg/m2
- ICU mortality [ Time Frame: through study completion, an average of 14 days ]number of fatal cases
- Invasive mechanical ventilation [ Time Frame: through study completion, an average of 14 days ]number of patients with invasive mechanical ventilation
- In-hospital mortality [ Time Frame: through study completion, an average of 21 days ]number of fatal cases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425213
|Centre hospitalo-universitaire régional de Nancy|
|Vandœuvre-lès-Nancy, France, 54511|
|Principal Investigator:||Olivier Ziegler, PU-PH||CHRU of Nancy|