Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
试验速览
- 阶段
- 不适用
- 发起方
- Theradial
- 入组人数
- 106
- 试验地点
- 24
- 主要终点
- Possible decrease mortality in patients arm treated with PEPA membrane
研究概览
简要总结
NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or HDF-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.
详细描述
The objective of NutriPEPA2 study is to demonstrate that the use of an adsorbent membrane (PEPA-Poly Ester Poly Arylate synthetic co-polymer membrane) decreases undernutrition (often associated with inflammation) and consequently morbidity, comparing one year mortality in patients with Chronic Kidney Disease (CKD), with severe Protein-Energy Wasting (PEW), treated with dialysis using a non-adsorbent synthetic membrane (Polysulfone or Polyethersulfone) versus an adsorbent membrane (PEPA).
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
- Single (Participant)
盲法说明
Patients will be randomized and included in one of the following 2 groups group 1: PEPA membrane / group 2: non-adsorbent synthetic membrane . The randomization will be stratified on the center
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 Chronic Renal Insufficiency Stage 5, treated by fistula or permanent catheters,
- •Medium albumin (on 3 recent assays) of less than 35 g / l (this assay being carried out by a non-electrophoretic technique),
- •PINI score greater than or equal to 1,
- •Beginning of the treatment of extra-renal purification by hemodialysis for at least 3 months on a non-adsorbing synthetic membrane (of the Polysulfone, Polyethersulfone, PolyArylethersulfone type) of surface at least equal to that of the PEPA dialyser
排除标准
- •Patients allergic to PEPA,
- •Patients with insufficient vascular access,
- •Patients with digestive syndromes: Hepatopathy, gastrointestinal amyloidosis, chronic diarrhea, myeloma and dysglobulinaemia, neoplasia and hematopathy, a serious illness that is life-threatening in the short term,
结局指标
主要结局
Possible decrease mortality in patients arm treated with PEPA membrane
时间窗: one year
Superiority of mortality with other non-adsorbent membrane versus adsorbent
次要结局
- Evolution of adipocytokines concentration(one year)