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临床试验/NCT02371018
NCT02371018已完成不适用

Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Changes in beat-to-beat systolic blood pressure

研究概览

简要总结

The purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design.

详细描述

The consumption of food or nutritional supplements during hemodialysis treatment has been shown to improve nutritional status, improve quality of life, and reduce mortality.

Despite these observations, allowing patients to eat food during hemodialysis treatment is sometimes restricted in the United States. The reasons for this restrictive policy are multi-factorial, but include concerns related to drops in blood pressure BP or a reduced efficiency of solute removal following eating during HD treatment. An alternative to eating solid food is to provide patients with liquid nutritional supplements. Clinics in the US are more likely to allow the consumption of liquid nutritional supplements, however, little is known about the effect that liquid supplements have on blood pressure or treatment efficiency. Therefore, the investigators plan to examine the effect of nutritional supplementation during hemodialysis treatment on hemodynamics and treatment efficiency in a crossover design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists

排除标准

  • Milk or soy allergy, more than 4 hypotensive events requiring intervention in the last two weeks, hospitalized due to hypotension in the previous week

研究组 & 干预措施

Standard Hemodialysis

No Intervention

Participants will be monitored during their normal hemodialysis treatment with no intervention administered

Hemodialysis with Nutrition Supplement

Experimental

Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro.

干预措施: Nepro (Dietary Supplement)

Nutrition Supplement

Experimental

Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment.

干预措施: Nepro (Dietary Supplement)

结局指标

主要结局

Changes in beat-to-beat systolic blood pressure

时间窗: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks

Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography

次要结局

  • Gastrointestinal symptoms during treatment by a rating scale(Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks)
  • Treatment efficiency measured by urea removal(Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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