Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in prealbumin levels
研究概览
简要总结
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.
In cases where primary treatment of malnutrition is not effective, intradialytic parenteral nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids, carbohydrates and fatty acids as well as vitamins and trace elements can be given to the patients.
Effectiveness of IDPN has to be verified.
详细描述
25% of hemodialysis patients who are treated for more than 5 years suffer from protein malnutrition. 7% have a protein catabolic rate less than 0,6 g/kgBW and day.
The conventional treatment of malnutrition include dietetic counseling, psychologic advice and giving additional oral nutrients.In many cases this kind of therapy is uneffective. If supplementary enteral nutrition is used, the additional intake of water has to be taken into consideration.
IDPN is a mode of treatment by which disadvantages of enteral nutrition and fluid overload of the patients can be avoided.During each dialysis session nutrients can be given and additional water simultaneously can be removed by ultrafiltration.
Some publications have shown that the catabolic state of the patients can be converted into an anabolic state. There are only small randomized studies showing the positive effect of IDPN.
In this german multicenter study malnourished hemodialysis patients are randomized into two groups. One group is treated with IDPN during each dialysis session for 16 weeks followed by 12 weeks of follow-up without IDPN. The control-group does not receive IDPN.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemodialysis therapy more than 6 months
- •three times per week hemodialysis
- •albumin < 35 g/l
- •prealbumin < 250 mg/l
- •phase angle < 4,5°
- •SGA score grade B or C
- •informed consent
排除标准
- •inadequate dialysis (Kt/V < 1,2)
- •chemotherapy or radiotherapy
- •cardiac pacemaker
- •acute bacterial infection
- •acute immunological disease
- •cancer disease
- •severe hepatic insufficiency
- •interferon therapy
- •HIV disease
- •severe diabetes mellitus
研究组 & 干预措施
Intradialytic parenteral nutrition
Individually compounded intradialytic parenteral nutrition (IDPN) including glucose, amino acids, lipids, L-Carnitine, trace elements and water-soluable vitamins 3x / week over 16 weeks + 12 weeks postinterventional observation.
干预措施: Intradialytic Parenteral Nutrition (IDPN) (Drug)
结局指标
主要结局
Change in prealbumin levels
时间窗: 8 weeks
次要结局
- Serum albumin, transferrin, nutritional status(8 weeks)