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

Shanghai Jiao Tong University

Status: Unknown

Conditions: COVID-19; Hemodiafiltration

Treatments: Behavioral: Nutrition consultation; Dietary Supplement: Oral nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05366205

RJYY01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Oral nutritional supplements

Experimental group

Description:

Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).

Treatment:

Dietary Supplement: Oral nutritional supplement

nutrition consultation

Sham Comparator group

Description:

Patients in this arm will receive nutrition consultation was given in addition to basic treatment.

Treatment:

Behavioral: Nutrition consultation