Clinical trial NCT05366205: Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Hemodiafiltration
Keywords: COVID-19
Hemodiafiltration
immune function
Oral nutritional supplement
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CD4 lymphocyte counts
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: lymphocyte count
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: T-lymphocyte subsets
timeFrame: Baseline to discharge date, an average of 3 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in white blood cell count
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in hemoglobin
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in albumin
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in C-Reactive Protein
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in procalcitonin
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in nutritional risk screening 2002(NRS 2002) score
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in mini nutritional assessment short-form（MNA- SF） score
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: change in Geriatric nutritional risk index(GNRI) score
timeFrame: Baseline to discharge date, an average of 3 weeks
measure: Length of hospital stay
timeFrame: Baseline to discharge date, an average of 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Yongmei Shi, MD
role: STUDY_CHAIR
References: