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

NCT00822653 — Not applicable, Withdrawn, Binghamton University
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the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life

RegistryNCT00822653
StatusWithdrawn - Original principal investigator left the university before enrollment started
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, prevention
SponsorBinghamton University (Other)
ConditionsHypotension
InterventionsCalf Muscle Pump Stimulation (Device)
Datesstart 2008-06-01, primary completion 2008-12-01, completion 2008-12-01, first posted 2009-01-14, last updated 2016-09-26

Related Papers Related Patents Related Grants Related Experts
All trials for Hypotension All trials of Calf Muscle Pump Stimulation

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Calf Muscle Pump StimulationExperimentalDevice: Calf Muscle Pump StimulationSubjects serve as self-control. Six weeks of dialysis data without intervention will be compared to six weeks post intervention
  • Calf Muscle Pump Stimulation (Device): Stimulation of the postural reflex arc to activate the soleus muscle during dialysis

+Outcome measures

Primary outcomes

  • Achievement of ultrafiltration goal [6 weeks]: Fraction of dialysis treatments where microfiltration target was achieved during 6 week period

Secondary outcomes

  • Hypotensive events [6 weeks]: Number of hypotensive events experienced during dialysis over six week time period

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators