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

NCT ID: NCT05366205

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-08-31

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.

Conditions

COVID-19; Hemodiafiltration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral nutritional supplements

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

Group Type: EXPERIMENTAL

Oral nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.

nutrition consultation

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

Group Type: SHAM_COMPARATOR

Nutrition consultation

Intervention Type: BEHAVIORAL

Nutritional treatment advice will be given

Interventions

Oral nutritional supplement

Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.

Intervention Type: DIETARY_SUPPLEMENT

Nutrition consultation

Nutritional treatment advice will be given

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

SHI YONGMEI

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongmei Shi, MD

Role: STUDY_CHAIR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Central Contacts

Yongmei Shi, MD

Role: CONTACT

shi.yongmei@163.com

00862164370045 ext. 673376

Qianwen Jin, MD

Role: CONTACT

jqw12247@rjh.com.cn

008618701708006

Other Identifiers

RJYY01

Identifier Type: -

Identifier Source: org_study_id