Pilot Study of Nutrition in Maintenance Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Meals
High-protein renal-specific meals
干预措施: Meals (Dietary Supplement)
Control
No Meals
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
- Vitality Score(9 weeks)
- Serum Creatinine(9 weeks)
- Serum Chloride(9 weeks)
- Serum CO2(9 weeks)
- 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 Adjusted Calcium(9 weeks)
- Serum Phosphate(9 weeks)
- Sleep Problems Index(9 weeks)
- Interdialytic Weight Gain(9 weeks)
研究者
Kathleen Hill Gallant
Assistant professor nutrition science
Purdue University