Iron Dosing Pilot Study Using Model Predictive Control
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of tsat values within range
研究概览
简要总结
This is a pilot study to test the utility of an integrated approach in the management of the anemia of chronic kidney disease through the administration of both an erythropoietic stimulating agent and iron. Subjects will be studied for 6 months during which all iron dosing will be recommended using a computer based tool using model predictive control. Comparisons will be made to the 6 months prior to enrollment in to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic kidney disease
- •receiving intravenous iron
排除标准
- 未提供
研究组 & 干预措施
Treatment
Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.
干预措施: Model predictive control (Device)
Treatment
Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.
干预措施: Model Predictive Control of Iron Dosing (Device)
结局指标
主要结局
Percentage of tsat values within range
时间窗: Monthly for 6 months
Tsat is measured as a percent saturation, desired range is 20 to 50%
次要结局
- Iron dose over ride by physician(Monthly for 6 months)
研究者
Alfred Jacobs
Assoc Professor
University of Louisville