跳至主要内容
临床试验/NCT02450474
NCT02450474Unknown不适用

Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis

The Leeds Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年2月1日最近更新:
适应症

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

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

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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