Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis
Primary Purpose
COVID-19, Hemodiafiltration
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral nutritional supplement
Nutrition consultation
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement
Eligibility Criteria
Inclusion Criteria:
- Aged 60 and above;
- Patients receiving hemodialysis with clinically confirmed end-stage renal disease
- Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type
- Patients who can eat on their own;
- Patients had good compliance, fully understood the study content and signed informed consent.
Exclusion Criteria:
- Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia.
- In an unstable state of vital signs such as shock.
- In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack
- Patients with moderate to severe cognitive impairment or mental diseases;
- People who are allergic to intestinal nutrients
- Refuse oral nutritional supplements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Oral nutritional supplements
nutrition consultation
Arm Description
Patients in this arm will receive oral nutritional supplements 24-48 hours after admission,which is enteral nutrition emulsion(TPF-T).
Patients in this arm will receive nutrition consultation was given in addition to basic treatment.
Outcomes
Primary Outcome Measures
CD4 lymphocyte counts
lymphocyte count
T-lymphocyte subsets
CD3+, CD4+, CD8+
Secondary Outcome Measures
Change in body weight
change in white blood cell count
change in hemoglobin
change in albumin
change in C-Reactive Protein
change in procalcitonin
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
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
change in Geriatric nutritional risk index(GNRI) score
Higher scores mean a worse outcome
Length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05366205
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Hemodiafiltration
Keywords
COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral nutritional supplements
Arm Type
Experimental
Arm Description
Patients in this arm will receive oral nutritional supplements 24-48 hours after admission,which is enteral nutrition emulsion(TPF-T).
Arm Title
nutrition consultation
Arm Type
Sham Comparator
Arm Description
Patients in this arm will receive nutrition consultation was given in addition to basic treatment.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral nutritional supplement
Intervention Description
Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition consultation
Intervention Description
Nutritional treatment advice will be given
Primary Outcome Measure Information:
Title
CD4 lymphocyte counts
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
lymphocyte count
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
T-lymphocyte subsets
Description
CD3+, CD4+, CD8+
Time Frame
Baseline to discharge date, an average of 3 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in white blood cell count
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in hemoglobin
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in albumin
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in C-Reactive Protein
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in procalcitonin
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in nutritional risk screening 2002(NRS 2002) score
Description
Scores range from 0 to 7,a score greater than or equal to 3 indicates nutritional risk
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in mini nutritional assessment short-form(MNA- SF) score
Description
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
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
change in Geriatric nutritional risk index(GNRI) score
Description
Higher scores mean a worse outcome
Time Frame
Baseline to discharge date, an average of 3 weeks
Title
Length of hospital stay
Time Frame
Baseline to discharge date, an average of 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 60 and above;
Patients receiving hemodialysis with clinically confirmed end-stage renal disease
Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type
Patients who can eat on their own;
Patients had good compliance, fully understood the study content and signed informed consent.
Exclusion Criteria:
Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia.
In an unstable state of vital signs such as shock.
In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack
Patients with moderate to severe cognitive impairment or mental diseases;
People who are allergic to intestinal nutrients
Refuse oral nutritional supplements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongmei Shi, MD
Phone
00862164370045
Ext
673376
Email
shi.yongmei@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qianwen Jin, MD
Phone
008618701708006
Email
jqw12247@rjh.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongmei Shi, MD
Organizational Affiliation
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis
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