Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Evolution of the nutritional status
研究概览
简要总结
Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.
详细描述
The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with renal failure, on hemodialysis for at least 12 months;
- •Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);
- •Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;
- •Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:
- •Patient who signed an informed consent form to participate in the study
排除标准
- •Known allergy to PEPA® ;
- •Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- •Patient with a chronic infection in progress;
- •Patient with life expectancy <6 months according to the investigator;
- •Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);
- •Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
Evolution of the nutritional status
时间窗: Month 6
The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.
次要结局
- Appearance of adverse events(Month 6)
- Measure of the Quality of life(Month 6)
- Evolution of nutritional assessment(Month 6)