COVID-19, Hemodiafiltration
Conditions
Keywords
COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement
Brief summary
This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.
Detailed description
COVID-19 is in the midst of a global pandemic. Elderly patients are often susceptible and at high risk. Elderly patients on maintenance hemodialysis are often accompanied by a variety of complications, malnutrition is a common complication with an incidence of 23-73%. Due to a variety of risk factors, COVID-19 infection tends to develop into severe disease, and it takes longer for nucleic acid to turn negative. This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.
Interventions
DIETARY_SUPPLEMENTOral nutritional supplement
Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.
BEHAVIORALNutrition consultation
Nutritional treatment advice will be given
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 60 and above; 2. Patients receiving hemodialysis with clinically confirmed end-stage renal disease 3. Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type 4. Patients who can eat on their own; 5. Patients had good compliance, fully understood the study content and signed informed consent.
Exclusion criteria
1. Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia. 2. In an unstable state of vital signs such as shock. 3. In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack 4. Patients with moderate to severe cognitive impairment or mental diseases; 5. People who are allergic to intestinal nutrients 6. Refuse oral nutritional supplements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD4 lymphocyte counts | Baseline to discharge date, an average of 3 weeks | — |
| lymphocyte count | Baseline to discharge date, an average of 3 weeks | — |
| T-lymphocyte subsets | Baseline to discharge date, an average of 3 weeks | CD3+, CD4+, CD8+ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in albumin | Baseline to discharge date, an average of 3 weeks | — |
| change in C-Reactive Protein | Baseline to discharge date, an average of 3 weeks | — |
| change in procalcitonin | Baseline to discharge date, an average of 3 weeks | — |
| Change in body weight | Baseline to discharge date, an average of 3 weeks | — |
| change in mini nutritional assessment short-form（MNA- SF） score | Baseline to discharge date, an average of 3 weeks | Scores range from 0 to 14，a score of 0 to 7 indicates malnutrition，8-11 indicates risk of malnutrition, 12-14 indicates normal nutrition |
| change in Geriatric nutritional risk index(GNRI) score | Baseline to discharge date, an average of 3 weeks | Higher scores mean a worse outcome |
| Length of hospital stay | Baseline to discharge date, an average of 3 weeks | — |
| change in nutritional risk screening 2002(NRS 2002) score | Baseline to discharge date, an average of 3 weeks | Scores range from 0 to 7，a score greater than or equal to 3 indicates nutritional risk |
| change in white blood cell count | Baseline to discharge date, an average of 3 weeks | — |
| change in hemoglobin | Baseline to discharge date, an average of 3 weeks | — |
Contacts
Primary ContactYongmei Shi, MD
Backup ContactQianwen Jin, MD
Outcome results
None listed