The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypotension

Intervention / Treatment
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* Device: Calf Muscle Pump Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calf Muscle Pump Stimulation<br>Subjects serve as self-control. Six weeks of dialysis data without intervention will be compared to six weeks post intervention | Device: Calf Muscle Pump Stimulation<br>* Stimulation of the postural reflex arc to activate the soleus muscle during dialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of ultrafiltration goal | Fraction of dialysis treatments where microfiltration target was achieved during 6 week period | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotensive events | Number of hypotensive events experienced during dialysis over six week time period | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis treatment, pump stimulation, reduce hypotensive episodes