The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Change in lean tissue mass
研究概览
简要总结
Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Undergoing chronic hemodialysis
排除标准
- •Life expectancy < 6 months
- •Planned kidney transplant within 4 months
- •Severe overhydration leading to respiratory insufficiency
- •Parenteral nutrition within four weeks prior to screening
- •Severe hepatic insufficiency
- •Pregnancy
- •Unipolar pacemaker with a very low sensitivity threshold
- •Active treatment for infection
- •Acute myocardial infarction
- •Circulatory shock
- •Hypersensitivity for any Olimel N12 ingredient or excipient
研究组 & 干预措施
Intervention
Intradialytic parenteral nutrition three times weekly during 16 weeks
干预措施: Olimel N12 (Drug)
Placebo
5% glucose three times weekly during 16 weeks
干预措施: Glucose IV (Drug)
结局指标
主要结局
Change in lean tissue mass
时间窗: 16 weeks
Measured by body composition monitor (BCM)
次要结局
- Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline(16 weeks)
- Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline(16 weeks)
- Change in phase angle from baseline(16 weeks)
- Skeletal muscle quality index (SMQI)(16 weeks)
- Change in adipose tissue mass from baseline(16 weeks)
- Change in hand grip strength from baseline(16 weeks)
- Positive and negative affect(16 weeks)
- Change in body weight from baseline(16 weeks)
- Change in serum prealbumin concentration from baseline(16 weeks)
研究者
Ewout Hoorn
Principal Investigator
Erasmus Medical Center