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

Primary Purpose

Hypotension

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calf Muscle Pump Stimulation
Sponsored by
Binghamton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring hemodialysis treatment, pump stimulation, reduce hypotensive episodes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Calf Muscle Pump Stimulation

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Achievement of ultrafiltration goal
    Fraction of dialysis treatments where microfiltration target was achieved during 6 week period

    Secondary Outcome Measures

    Hypotensive events
    Number of hypotensive events experienced during dialysis over six week time period

    Full Information

    First Posted
    January 13, 2009
    Last Updated
    September 22, 2016
    Sponsor
    Binghamton University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00822653
    Brief Title
    The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis
    Official Title
    the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Original principal investigator left the university before enrollment started
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Binghamton University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension
    Keywords
    hemodialysis treatment, pump stimulation, reduce hypotensive episodes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Calf Muscle Pump Stimulation
    Arm Type
    Experimental
    Arm Description
    Subjects serve as self-control. Six weeks of dialysis data without intervention will be compared to six weeks post intervention
    Intervention Type
    Device
    Intervention Name(s)
    Calf Muscle Pump Stimulation
    Intervention Description
    Stimulation of the postural reflex arc to activate the soleus muscle during dialysis
    Primary Outcome Measure Information:
    Title
    Achievement of ultrafiltration goal
    Description
    Fraction of dialysis treatments where microfiltration target was achieved during 6 week period
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Hypotensive events
    Description
    Number of hypotensive events experienced during dialysis over six week time period
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth J. McLeod, Ph.D.
    Organizational Affiliation
    Clinical Science and Engineering Research Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Team is willing to share anonymous data with interested investigators

    Learn more about this trial

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

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