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临床试验/NCT02917278
NCT02917278已完成不适用

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Purdue University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Hypotensive Event Frequency

研究概览

简要总结

This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Men and women
  • Age 18 years or older
  • Maintenance hemodialysis patients

排除标准

  • Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding

结局指标

主要结局

Hypotensive Event Frequency

时间窗: 9 weeks

frequency of hypotensive events that require intervention during dialysis

次要结局

  • Blood Glucose(9 weeks)
  • Serum Sodium(9 weeks)
  • Hunger Rating(9 weeks)
  • Mean Arterial Pressure (mm Hg)(9 weeks)
  • Serum Albumin(9 weeks)
  • Blood Urea Nitrogen(9 weeks)
  • Serum Pre-albumin(9 weeks)
  • Dialysis Absences(9 weeks)
  • Serum Phosphate(9 weeks)
  • Serum Adjusted Calcium(9 weeks)
  • Vitality Score(9 weeks)
  • Serum Creatinine(9 weeks)
  • Serum Chloride(9 weeks)
  • Serum CO2(9 weeks)
  • Sleep Problems Index(9 weeks)
  • Interdialytic Weight Gain(9 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Hill Gallant

Assistant professor nutrition science

Purdue University

研究点 (2)

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