Obesity and Mortality of Critically Ill Patients With COVID-19

Completed

• Conditions: Severe Acute Respiratory Syndrome; COVID; Obesity; Comorbidities and Coexisting Conditions

• Registration Number: NCT04425213
• Lead Sponsor: Central Hospital, Nancy, 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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-12
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-26
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU mortality	through study completion, an average of 14 days	number of fatal cases

Secondary Outcome Measures

Name	Time	Method
Invasive mechanical ventilation	through study completion, an average of 14 days	number of patients with invasive mechanical ventilation
In-hospital mortality	through study completion, an average of 21 days	number of fatal cases

Trial Locations

Locations (1)

Centre hospitalo-universitaire régional de Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France