Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized Controlled Study on Immune Function Regulation by Strengthening Early Oral Nutritional Supplementation in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis

Conditions
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COVID-19, Hemodiafiltration

Intervention / Treatment
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* Dietary Supplement: Oral nutritional supplement
* Behavioral: Nutrition consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60 and above; Patients receiving hemodialysis with clinically confirmed end-stage renal disease Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type Patients who can eat on their own; Patients had good compliance, fully understood the study content and signed informed consent. Exclusion Criteria: Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia. In an unstable state of vital signs such as shock. In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack Patients with moderate to severe cognitive impairment or mental diseases; People who are allergic to intestinal nutrients Refuse oral nutritional supplements

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral nutritional supplements<br>Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T). | Dietary Supplement: Oral nutritional supplement<br>* Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.<br>|
| Sham Comparator: nutrition consultation<br>Patients in this arm will receive nutrition consultation was given in addition to basic treatment. | Behavioral: Nutrition consultation<br>* Nutritional treatment advice will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | CD3+, CD4+, CD8+ | Baseline to discharge date, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline to discharge date, an average of 3 weeks | 
| 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 | 
| 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 nutritional risk screening 2002(NRS 2002) score | Scores range from 0 to 7，a score greater than or equal to 3 indicates nutritional risk | Baseline to discharge date, an average of 3 weeks | 
| change in mini nutritional assessment short-form（MNA- SF） score | 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 | Baseline to discharge date, an average of 3 weeks | 
| change in Geriatric nutritional risk index(GNRI) score | Higher scores mean a worse outcome | Baseline to discharge date, an average of 3 weeks | 
| Length of hospital stay |  | Baseline to discharge date, an average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement