Clinical trial NCT04425213: Obesity and Mortality of Critically Ill Patients With COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Severe Acute Respiratory Syndrome
Obesity
Comorbidities and Coexisting Conditions
Keywords: Mortality
Covid-19
Invasive mechanical ventilation
Obesity
Acute Respiratory Distress syndrome
Intensive Care Unit
Critically ill patient
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to ICUs of the University Hospital during the first Covid -19 wave in Nancy, Région Grand Est, France

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients with COVID-19 pneumonia admitted to ICUs between February 27th and April 18th 2020.
* Infection confirmed by reverse transcriptase polymerase chain reaction assay or radiologically by chest computed tomography scan

Exclusion Criteria:

* No weight or height measurement available in the medical files

Primary outcomes:
measure: ICU mortality
timeFrame: through study completion, an average of 14 days
Secondary outcomes:
measure: Invasive mechanical ventilation
timeFrame: through study completion, an average of 14 days
measure: In-hospital mortality
timeFrame: through study completion, an average of 21 days
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Centre hospitalo-universitaire régional de Nancy
Study officials:
affiliation: CHRU of Nancy
name: Olivier Ziegler, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: