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

Not Applicable

• Conditions: COVID-19; Hemodiafiltration
• Interventions: Dietary Supplement: Oral nutritional supplement; Behavioral: Nutrition consultation

• Registration Number: NCT05366205
• Lead Sponsor: Ruijin Hospital

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 Timeline

• Study First Submitted: 2022-04-30
• Status Verified: 2022-05
• Study Start: 2022-05-01
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Primary Completion: 2022-07-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral nutritional supplements	Oral nutritional supplement	Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).
nutrition consultation	Nutrition consultation	Patients in this arm will receive nutrition consultation was given in addition to basic treatment.

Primary Outcome Measures

Name	Time	Method
T-lymphocyte subsets	Baseline to discharge date, an average of 3 weeks	CD3+, CD4+, CD8+
CD4 lymphocyte counts	Baseline to discharge date, an average of 3 weeks
lymphocyte count	Baseline to discharge date, an average of 3 weeks

Secondary Outcome Measures

Name	Time	Method
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	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
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 C-Reactive Protein	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