Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in 24-hour Mean Arterial Pressure (MAP)
研究概览
简要总结
The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypertension
- •CKD stage 2-5
- •requiring antihypertensive medication per clinician judgement.
排除标准
- •renal transplant anticipated or occurred within 6 months of screening
- •transfer out of our practice setting anticipated within 6 months
- •unable to complete 24 hour arterial blood pressure monitoring (ABPM) due to developmental or behavioral limitations
研究组 & 干预措施
n-of-1 trial guided clinical decision making
干预措施: n-of-1 trial guided clinical decision making (Procedure)
结局指标
主要结局
Change in 24-hour Mean Arterial Pressure (MAP)
时间窗: baseline, 6 months
24-hour mean arterial pressure (MAP) is the mean arterial pressure over 24 hours \[ambulatory blood pressure monitoring (ABPM) will be used to record blood pressure every 20 min for 24 hours, and all recordings will be averaged to obtain 24-hour MAP\]. 24-hour MAP will be assessed at baseline and at 6 months, and the change between baseline and 6-months will be reported.
次要结局
- Number of Participants With Target Blood Pressure(baseline)
- Number of Participants With Target Blood Pressure(6 months)
研究者
Joyce Philip Samuel
Associate Professor
The University of Texas Health Science Center, Houston