Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Fluid Status (Body composition monitor measurement of fluid status)
研究概览
简要总结
Cardiovascular disease is the leading cause of death of dialysis patients and poor fluid management is associated with the increased risk. One of the principal limitations in avoiding chronic fluid overload in this patient group is the refilling rate the rate at which fluid is transferred from tissues into the vascular system. If this rate cannot match the prescribed rate of fluid removal during dialysis the patient will end up with chronic fluid overload.
Two proposed methods of increasing the rate of refilling are intermittent pneumatic compression (IPC) devices, which increase the pressure of the fluid in tissue, and neuromuscular electrical stimulation (NMES) which activates the muscle pump and lymphatic drainage.
This investigation will trial the use of these two methods in patients suspected of having inadequate refilling rates. Outcome measures will be based on fluid status, presence of oedema and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Presence of lower limb oedema as defined by pitting
- •Average post dialysis fluid overload in relation to target weight greater than 0.5 litres
- •Greater than one dialysis session that included an intradialytic hypotensive episode in the previous month, defined by saline influsion or nursing intervention
排除标准
- •Less than 18 years of age
- •Less than 3 months dialysis vintage
- •Presence of metal implants, amputations or the inability to be weighed
结局指标
主要结局
Fluid Status (Body composition monitor measurement of fluid status)
时间窗: Weekly
Body composition monitor measurement of fluid statu
Quality of Life (Validated Kidney Disease Quality of Life (KDQOL36) quality of life measurement questionnaire and patient symptom questionnaire)
时间窗: Weekly
Validated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire
次要结局
未报告次要终点
