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
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 主要终点
- T-lymphocyte subsets
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
T-lymphocyte subsets
时间窗: Baseline to discharge date, an average of 3 weeks
CD3+, CD4+, CD8+
CD4 lymphocyte counts
时间窗: Baseline to discharge date, an average of 3 weeks
lymphocyte count
时间窗: Baseline to discharge date, an average of 3 weeks
次要结局
- change in procalcitonin(Baseline to discharge date, an average of 3 weeks)
- change in mini nutritional assessment short-form（MNA- SF） score(Baseline to discharge date, an average of 3 weeks)
- change in Geriatric nutritional risk index(GNRI) score(Baseline to discharge date, an average of 3 weeks)
- change in albumin(Baseline to discharge date, an average of 3 weeks)
- Change in body weight(Baseline to discharge date, an average of 3 weeks)
- Length of hospital stay(Baseline to discharge date, an average of 3 weeks)
- change in hemoglobin(Baseline to discharge date, an average of 3 weeks)
- change in white blood cell count(Baseline to discharge date, an average of 3 weeks)
- change in C-Reactive Protein(Baseline to discharge date, an average of 3 weeks)
- change in nutritional risk screening 2002(NRS 2002) score(Baseline to discharge date, an average of 3 weeks)
研究者
SHI YONGMEI
associate chief physician
Ruijin Hospital