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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Binghamton University

ClinicalTrials.gov Identifier:

NCT00822653

First received: January 13, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Purpose

For the 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
Hypotension	Device: Effects of Plantar Stimulation

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Dialysis Low Blood Pressure

U.S. FDA Resources

Further study details as provided by Binghamton University:

Primary Outcome Measures:

Effects of Plantar Stimulation on Hypotension during Hemodialysis With Adults [ Time Frame: 4 hour treatments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effects of Plantar Stimulation on Treatment Efficacy With Adults on Hemodialysis [ Time Frame: 4 hour treatment ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	June 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Plantar stimulation:

Use of a low-intensity mechanical stimulus to the plantar surface (sole) so as to trigger a reflex response causing soleus muscle contraction, and thereby an increase in calf muscle pump activity. The plantar stimulation device (VStim; Juvent Medical Inc., Somerset, NJ) delivers a 50 micrometer displacement to the plantar surface of the foot at 45 Hz. This device has been shown to significantly increase lower limb blood and lymphatic flow when patients use the device while in a seated or supine position.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	MaryAnn Nemcek, Binghamton University
ClinicalTrials.gov Identifier:	NCT00822653 History of Changes
Other Study ID Numbers:	521-07
Study First Received:	January 13, 2009
Last Updated:	January 13, 2009
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by Binghamton University:

hemodialysis treatment
pump stimulation
reduce hypotensive episodes

Additional relevant MeSH terms:

Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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