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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by (Responsible Party):
Kenneth McLeod, Binghamton University
ClinicalTrials.gov Identifier:
NCT00822653
First received: January 13, 2009
Last updated: September 22, 2016
Last verified: September 2016

January 13, 2009
September 22, 2016
June 2008
December 2008   (final data collection date for primary outcome measure)
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
Effects of Plantar Stimulation on Hypotension during Hemodialysis With Adults [ Time Frame: 4 hour treatments ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00822653 on ClinicalTrials.gov Archive Site
Hypotensive events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Number of hypotensive events experienced during dialysis over six week time period
Effects of Plantar Stimulation on Treatment Efficacy With Adults on Hemodialysis [ Time Frame: 4 hour treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypotension
Device: Calf Muscle Pump Stimulation
Stimulation of the postural reflex arc to activate the soleus muscle during dialysis
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
Intervention: Device: Calf Muscle Pump Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00822653
521-07
No
Yes
Team is willing to share anonymous data with interested investigators
Kenneth McLeod, Binghamton University
Binghamton University
Not Provided
Principal Investigator: Kenneth J. McLeod, Ph.D. Clinical Science and Engineering Research Center
Binghamton University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP