EUCTR2018-003899-13-NL进行中（未招募）1 期
The effect of IntraDialytic Parenteral Nutrition on nutritional status and quality of life in hemodialysis patients - IDPN-Study
未提供0 个研究点目标入组 206 人开始时间: 2018年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 206
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age: = 18 years
- •Hemodialysis, 3 times / week, minimum 3,5 hours / session.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 126
排除标准
- •Life expectancy < 6 months
- •Planned kidney transplant within 4 months
- •Active treatment for infection
- •Parenteral nutrition for at least four weeks prior to screening
- •Unipolar pacemaker with a very low sensitivity threshold
- •Regular exclusion criteria for the use of parenteral nutrition in hemodialysis patients:
- •Severe overhydration leading to respiratory insufficiency.
- •Hypersensitivity for any ingredient or excipients
- •Severe hepatic insufficiency, total bilirubin > 20 µmol/l, ASAT + ALAT: > 3 times higher
- •than reference values.
- •Acute phase of circulatory shock
- •Acute myocardial infarction
- •Severe sepsis
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