Nutrition Disorders Clinical Trial
— DenutCOVIDOfficial title:
Nutritional Assessment of French Hospitalized Patients Infected With COVID-19
NCT number | NCT04503525 |
Other study ID # | RC-P00100 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 25, 2020 |
Est. completion date | June 30, 2021 |
Verified date | January 2022 |
Source | Lille Catholic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 90 |
Est. completion date | June 30, 2021 |
Est. primary completion date | May 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Saint-Vincent Hospital | Lille | Haut-de-France |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nutritional status of COVID infected patients | 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 | Correlation between the nutritional status and the supplemental oxygen requirement | 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 | |
Secondary | Correlation between the nutritional status and the prognostic after hospitalization | 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 |
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