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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00822653
Enrollment
0
Registered
2009-01-14
Start date
2008-06-30
Completion date
2008-12-31
Last updated
2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

hemodialysis treatment, pump stimulation, reduce hypotensive episodes

Brief summary

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

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.

Interventions

Stimulation of the postural reflex arc to activate the soleus muscle during dialysis

Sponsors

Binghamton University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Achievement of ultrafiltration goal6 weeksFraction of dialysis treatments where microfiltration target was achieved during 6 week period

Secondary

MeasureTime frameDescription
Hypotensive events6 weeksNumber of hypotensive events experienced during dialysis over six week time period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026