Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19

Covid-19 Clinical Trial

— NutriCoviDom  

Official title:

Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451694
• Other study ID #: 2020PI097
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid-19

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