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

This study has been withdrawn prior to enrollment.
(Original principal investigator left the university before enrollment started)
Information provided by (Responsible Party):
Kenneth McLeod, Binghamton University Identifier:
First received: January 13, 2009
Last updated: September 22, 2016
Last verified: September 2016
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.

Condition Intervention
Device: Calf Muscle Pump Stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life

Resource links provided by NLM:

Further study details as provided by Binghamton University:

Primary Outcome Measures:
  • Achievement of ultrafiltration goal [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Fraction of dialysis treatments where microfiltration target was achieved during 6 week period

Secondary Outcome Measures:
  • Hypotensive events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number of hypotensive events experienced during dialysis over six week time period

Enrollment: 0
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calf Muscle Pump Stimulation
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
Stimulation of the postural reflex arc to activate the soleus muscle during dialysis

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00822653

Sponsors and Collaborators
Binghamton University
Principal Investigator: Kenneth J. McLeod, Ph.D. Clinical Science and Engineering Research Center
  More Information

Responsible Party: Kenneth McLeod, Professor, BioEngineering, Binghamton University Identifier: NCT00822653     History of Changes
Other Study ID Numbers: 521-07 
Study First Received: January 13, 2009
Last Updated: September 22, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Team is willing to share anonymous data with interested investigators

Keywords provided by Binghamton University:
hemodialysis treatment
pump stimulation
reduce hypotensive episodes

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on October 21, 2016