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

Binghamton University

Status: Withdrawn

Conditions: Hypotension

Treatments: Device: Calf Muscle Pump Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00822653

521-07

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older;
2. alert and oriented to time, place, and self;
3. able to read and speak the English language;
4. currently receiving hemodialysis treatment approximately 3-4 hour sessions, 3 times a week;
5. received hemodialysis treatments continuously for the several previous months; AND
6. consistently exhibits hypotensive symptoms during dialysis.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Calf Muscle Pump Stimulation

Experimental group

Description:

Subjects serve as self-control. Six weeks of dialysis data without intervention will be compared to six weeks post intervention

Treatment:

Device: Calf Muscle Pump Stimulation