跳至主要内容
临床试验/NCT00822653
NCT00822653撤回不适用

the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life

Binghamton University0 个研究点开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Achievement of ultrafiltration goal

研究概览

简要总结

For the end stage renal disease (ESRD) patients undergoing hemodialysis treatment, specifically, reflex mediated calf muscle pump stimulation has the potential to significantly reduce the number and magnitude of hypotensive episodes thus enhancing the effectiveness of the dialysis process. Fewer hemodialysis complications during the patient's hemodialysis treatment, would allow treatment sessions to continue to the prescribed volume removal, with much reduced patient recovery time, and the costs associated with this recovery.

详细描述

Recruit individuals who consistently miss their dialysis goal. Maintain the goal over a six week period of time. Utilize exogenous calf muscle pump stimulation during each dialysis session to enhance fluid return from the lower limbs with the objective of assisting the patient in reaching ultrafiltration goal.

Track number of hypotensive events during dialysis, as well as goal success.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • 18 years of age or older;
  • alert and oriented to time, place, and self;
  • able to read and speak the English language;
  • currently receiving hemodialysis treatment approximately 3-4 hour sessions, 3 times a week;
  • received hemodialysis treatments continuously for the several previous months; AND
  • consistently exhibits hypotensive symptoms during dialysis.

排除标准

  • receiving hemodialysis as a temporary treatment following a peritoneal dialysis complication or an episode of transplant rejection;
  • receiving hemodialysis at home; OR
  • if they have a Medical History of any the following conditions: deep venous thrombosis, uncontrolled hypertension, pulmonary embolus

结局指标

主要结局

Achievement of ultrafiltration goal

时间窗: 6 weeks

Fraction of dialysis treatments where microfiltration target was achieved during 6 week period

次要结局

  • Hypotensive events(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth McLeod

Professor, BioEngineering

Binghamton University

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