Obesity and Mortality of Critically Ill Patients With COVID-19

NCT ID: NCT04425213

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-12

Study Completion Date

2020-05-26

Brief Summary

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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

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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.

Conditions

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COVID Severe Acute Respiratory Syndrome Obesity Comorbidities and Coexisting Conditions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal weight

BMI \< 25 kg/m2

No interventions assigned to this group

Overweight

BMI : 25 - 29.9 kg/m2

No interventions assigned to this group

Moderate obesity

BMI : 30 - 39.9 kg/m2

No interventions assigned to this group

Severe obesity

BMI : \> or = 40 kg/m2

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Ziegler, PU-PH

Role: PRINCIPAL_INVESTIGATOR

CHRU of Nancy

Locations

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Centre hospitalo-universitaire régional de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2020PI082

Identifier Type: -

Identifier Source: org_study_id

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