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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
COVID Severe Acute Respiratory Syndrome Obesity Comorbidities and Coexisting Conditions

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.

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Normal weight
BMI < 25 kg/m2
Overweight
BMI : 25 - 29.9 kg/m2
Moderate obesity
BMI : 30 - 39.9 kg/m2
Severe obesity
BMI : > or = 40 kg/m2



Primary Outcome Measures :
  1. ICU mortality [ Time Frame: through study completion, an average of 14 days ]
    number of fatal cases


Secondary Outcome Measures :
  1. Invasive mechanical ventilation [ Time Frame: through study completion, an average of 14 days ]
    number of patients with invasive mechanical ventilation

  2. In-hospital mortality [ Time Frame: through study completion, an average of 21 days ]
    number of fatal cases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

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


Locations
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France
Centre hospitalo-universitaire régional de Nancy
Vandœuvre-lès-Nancy, France, 54511
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Olivier Ziegler, PU-PH CHRU of Nancy
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04425213    
Other Study ID Numbers: 2020PI082
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Mortality
Covid-19
Invasive mechanical ventilation
Obesity
Acute Respiratory Distress syndrome
Intensive Care Unit
Critically ill patient
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Obesity
Critical Illness
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Disease Attributes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases