Nutritional Assessment of Hospitalized Patients With COVID-19 (DenutCOVID)

January 5, 2022 updated by: Lille Catholic University

Nutritional Assessment of French Hospitalized Patients Infected With COVID-19

The nutritional consequences of the infection by the SARS-CoV-2 are as follows:

  • A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased.
  • Food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance.

Then, it is important to asses the nutritional status of COVID patients hospitalized in conventional COVID units (excluding intensive care).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Haut-de-France
      • Lille, Haut-de-France, France, 59000
        • Saint-Vincent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with COVID 19 disease

Description

Inclusion Criteria:

  • Patient on conventional hospitalization (duration less than 72 hours)
  • Age > 18 years old
  • COVID 19 diagnosed by Real Time Polymerase Chain Reaction (RT-PCR)
  • Patient agreed to participate in the study
  • Patient affiliated to French social security

Exclusion Criteria:

  • Patient hospitalized in intensive care units during more than 72 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID 19 hospitalized patients
COVID 19 infected patients admitted in conventional hospitalization for less than 72 hours
Other: Nutritional assessment
Nutritional assessment in COVID patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status of COVID infected patients
Time Frame: Up to 72 hours

The nutritional status of patients within the first 72 hours after hospital admission will be categorized according to the French Haute Authorité de Santé (France, 2019)

  • non-malnourished patient
  • moderately malnourished patient
  • severely malnourished patient
Up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the nutritional status and the supplemental oxygen requirement
Time Frame: Up to 72 hours

The supplemental oxygen requirement classified as follows:

  • non-severe: no need of Oxygen
  • light: 1 - 2 l/min
  • moderate: 3 - 5 l/min
  • severe: > 5 l/min
  • critical: mechanical ventilation
Up to 72 hours
Correlation between the nutritional status and the prognostic after hospitalization
Time Frame: Up to 72 hours

The prognostic after hospitalization will be classified as follows:

  • Hospital discharge
  • Transfer to the intensive care unit
  • Transfer to other unit
  • Follow-up care and rehabilitation
  • Death
Up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Arnaud Cortet, MD, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2020

Primary Completion (ACTUAL)

May 25, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (ACTUAL)

August 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 6, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P00100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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