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

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ClinicalTrials.gov Identifier: NCT00822653
Recruitment Status : Withdrawn (Original principal investigator left the university before enrollment started)
First Posted : January 14, 2009
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypotension Device: Calf Muscle Pump Stimulation

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life
Study Start Date : June 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Achievement of ultrafiltration goal [ Time Frame: 6 weeks ]
    Fraction of dialysis treatments where microfiltration target was achieved during 6 week period


Secondary Outcome Measures :
  1. Hypotensive events [ Time Frame: 6 weeks ]
    Number of hypotensive events experienced during dialysis over six week time period


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822653


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

Responsible Party: Kenneth McLeod, Professor, BioEngineering, Binghamton University
ClinicalTrials.gov Identifier: NCT00822653     History of Changes
Other Study ID Numbers: 521-07
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Team is willing to share anonymous data with interested investigators

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

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases