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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05366205
• Other study ID #: RJYY01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2022
• Source: Ruijin Hospital
• Contact: Yongmei Shi, MD
• Phone: 00862164370045
• Email: shi.yongmei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: August 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Hemodiafiltration

Intervention

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

Behavioral:
• Nutrition consultation
Nutritional treatment advice will be given

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 lymphocyte counts		Baseline to discharge date, an average of 3 weeks
Primary	lymphocyte count		Baseline to discharge date, an average of 3 weeks
Primary	T-lymphocyte subsets	CD3+, CD4+, CD8+	Baseline to discharge date, an average of 3 weeks
Secondary	Change in body weight		Baseline to discharge date, an average of 3 weeks
Secondary	change in white blood cell count		Baseline to discharge date, an average of 3 weeks
Secondary	change in hemoglobin		Baseline to discharge date, an average of 3 weeks
Secondary	change in albumin		Baseline to discharge date, an average of 3 weeks
Secondary	change in C-Reactive Protein		Baseline to discharge date, an average of 3 weeks
Secondary	change in procalcitonin		Baseline to discharge date, an average of 3 weeks
Secondary	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
Secondary	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
Secondary	change in Geriatric nutritional risk index(GNRI) score	Higher scores mean a worse outcome	Baseline to discharge date, an average of 3 weeks
Secondary	Length of hospital stay		Baseline to discharge date, an average of 3 weeks