NCT05333692已完成不适用
Oral Nutritional Supplementation of Hemodialysis Patients
Fresenius Kabi Taiwan Ltd.2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Serum Albumin level change
研究概览
简要总结
This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years
- •Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
- •Malnutrition patients. Definition of Malnutrition is serum albumin level<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.
排除标准
- •BMI<18.5 and calorie intake unable to reach 50% of the recommended level
- •BMI>30 kg/m2,
- •abnormal liver function,
- •malignant disease,
- •scheduled surgery within a month or after surgery,
- •infectious disease,
- •suboptimal tolerance of nutritional supplements,
- •inflammatory bowel disease, bowel obstruction,
- •acute condition complicated with multiple organ failure or under palliative care.
结局指标
主要结局
Serum Albumin level change
时间窗: baseline, weerk 4 and week 8
次要结局
- Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change(baseline, weerk 4 and week 8)
研究者
研究点 (2)
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