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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral nutritional supplements | Experimental | Patients in this arm will receive oral nutritional supplements 24-48 hours after admission,which is enteral nutrition emulsion(TPF-T). |
|
| nutrition consultation | Sham Comparator | Patients in this arm will receive nutrition consultation was given in addition to basic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nutritional supplement | Dietary Supplement | Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days. |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongmei Shi, MD | Contact | 00862164370045 | 673376 | shi.yongmei@163.com |
| Qianwen Jin, MD | Contact | 008618701708006 | jqw12247@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongmei Shi, MD | Ruijin Hospital | Study Chair |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Nutrition consultation | Behavioral | Nutritional treatment advice will be given |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |