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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04451694
Other study ID # 2020PI097
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date November 30, 2020

Study information

Verified date June 2020
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity.

An early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date November 30, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Covid positive (RT-PCR)

Exclusion Criteria:

- Unable to answer questions by telephone or teleconsultation directly or through a relative, minors under 16 years of age

Study Design


Related Conditions & MeSH terms


Intervention

Other:
nutritional intervention
nutritional evaluation and intervention and orientation towards adapted care establishment

Locations

Country Name City State
France Quilliot VANDOEUVRE LES Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary nutritional evaluation weight before Covid, at hospital discharge and between 7 and 45 days after discharge
Primary nutritional evaluation BMI before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
Secondary muscle strenght hand grip at the time of hospital admission and at the time of hospital discharge
Secondary food intake Caloric account at the time of hospital admission, at the time of hospital discharge
Secondary food intake self evaluation of food intake between 7 and 45 days after discharge
Secondary muscle strenght self evaluation of muscle strenght between 7 and 45 days after discharge
Secondary biological nutritional status albuminemia transthyretinemia electrolytes dosage inflammation status at the time of hospital admission, at the time of hospital discharge
Secondary anosmia anosmia and agueusia evolution at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
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