COVID-19
Conditions
Keywords
covid-19, ICU, respiratory support, quality of life, physical recovery
Brief summary
The goal of this low-interventional study was to learn about the effect a nutritional supplement in patients with COVID-19 and respiratory support. The main questions it aimed to answer were: * if additional nutrition support has an effect on recovery of physical health in patients with COVID-19; * to examine the effect of additional nutrition support on quality of life of patients with COVID-19; * to examine the effect of the additional nutrition support on hospitalization period of patients with COVID-19. Participants were split into two groups. One group had the common hospital diet, another group in addition to the common diet was given with NutriDrink® 200 ml X 2 daily. During the observation period participants were asked to measure hand strength measured by hand grip tester and fill out the quality of life standard questionnaire SF-36. In addition, several routine blood tests were performed.
Interventions
DIETARY_SUPPLEMENTNutridrink ONS 200 ml
Nutridrink is a high-protein, high-calorie formula for the specialized nutrition of patients with or at risk of malnutrition. The product can be used as an additional or sole source of nutrition
Sponsors
Danone Nutricia
Enrollme.ru, LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed new coronavirus infection COVID-19 (based on laboratory and/or computer tomography data); * Need in respiratory support (oxygen insufflation, non-invasive lung ventilation, artificial lung ventilation, as well in a prone position); * Ability to take food spontaneously in the amount of 60% and more of energy and protein needs (possibility of spontaneous food intake will be determined with the three-swallow test; consumed food will be controlled with the quarter of a plate method); * The informed consent is signed by a patient for the study enrollment and processing of personal data.
Exclusion criteria
* Diabetes mellitus; * Renal failure; * Hepatic failure; * Systemic disease; * Active cancer; * Poor survival prognosis. * Aggravation of a patient's condition requiring his transfer to enteral feeding and/or parenteral nutrition; * Occurrence of complications requiring surgical interventions; * Patient's transfer for treatment to another inpatient unit; * Complications induced by the product for additional nutrition support (diarrhea, nausea, vomiting); * Withdrawal of the informed consent for the study enrollment and processing of personal data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in handgrip (decanewton) strength between visits 3 and 1 | between inclusion and discharge from hospital (about 2-3 weeks) | Hand grip measured with hand dynamometer |
| Quality of life score, part Physical Health component according to the SF-36 questionnaire | up to 4 weeks | SF-36 questionnaire |
| Quality of life score, part Mental Health component according to the SF-36 questionnaire | up to 4 weeks | SF-36 questionnaire |
| Quality of life score Total Quality of Life according to the SF-36 questionnaire | up to 4 weeks | SF-36 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration (days) of the patient stay under respiratory support or in the intensive care unit | during observation | Medical record |
| Total stay in the hospital (days) | during observation | Medical record |
| Severity of the current status according to the Post-COVID19 Functional Status (PCFS) Scale | during observation | PCFS is not validated but usefull tool to measure patients' functional status https://erj.ersjournals.com/content/56/1/2001494 |
| Nutritional Impact Symptom (NIS) Check-list score | during observation | check-list and scale developed for cachexia patients and published in https://link.springer.com/article/10.1007/s13539-012-0099-x |
Countries
Russia
Outcome results
None listed