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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ruijin Hospital
- Enrollment
- 112
- Primary Endpoint
- T-lymphocyte subsets
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Oral nutritional supplements
Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).
Intervention: Oral nutritional supplement (Dietary Supplement)
nutrition consultation
Patients in this arm will receive nutrition consultation was given in addition to basic treatment.
Intervention: Nutrition consultation (Behavioral)
Outcomes
Primary Outcomes
T-lymphocyte subsets
Time Frame: Baseline to discharge date, an average of 3 weeks
CD3+, CD4+, CD8+
CD4 lymphocyte counts
Time Frame: Baseline to discharge date, an average of 3 weeks
lymphocyte count
Time Frame: Baseline to discharge date, an average of 3 weeks
Secondary Outcomes
- 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 mini nutritional assessment short-form（MNA- SF） score(Baseline to discharge date, an average of 3 weeks)
- change in Geriatric nutritional risk index(GNRI) score(Baseline to discharge date, an average of 3 weeks)
- change in albumin(Baseline to discharge date, an average of 3 weeks)
- Change in body weight(Baseline to discharge date, an average of 3 weeks)
- Length of hospital stay(Baseline to discharge date, an average of 3 weeks)
- change in hemoglobin(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 nutritional risk screening 2002(NRS 2002) score(Baseline to discharge date, an average of 3 weeks)
Investigators
SHI YONGMEI
associate chief physician
Ruijin Hospital