Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- intradialytic hypotension episodes
研究概览
简要总结
It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. It might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person.
The investigators hypothesize that a blood pressure guided biofeedback system (called BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.
详细描述
This is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, IDH will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (BioLogics RR Comfort, B braun). After the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study.
The primary outcome is the reduction in the number of IDH episodes associated with patient symptoms or nursing symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hemodialysis patients
- •history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions
排除标准
- •<19 years
- •hemodiafiltration
- •expected switch in modality within next 6 months
结局指标
主要结局
intradialytic hypotension episodes
时间窗: By the end of the 8 week intervention period
A 30% reduction in the frequency of HD sessions complicated by IDH. IDH is defined as a reduction in systolic BP of \> = 20 mmHg if the pre-dialysis BP is \>= 100 mmHg and with patient symptoms or nursing intervention. IDH is defined as a reduction in systolic BP of \>=10 mmHg if predialysis BP \< = 90mm Hg and with patient symptoms or nursing interventions
次要结局
- urea clearance(8 weeks)
- Brain natriuretic peptide(8 weeks)
- intradialytic hypotension (blood pressure criteria alone)(8 weeks)
- Intradialytic symptoms(8 weeks)
研究者
Dr Jennifer MacRae
Primary Investigator
University of Calgary