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

NCT ID: NCT00822653

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-12-31

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.

Conditions

Hypotension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Calf Muscle Pump Stimulation

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

Group Type: EXPERIMENTAL

Calf Muscle Pump Stimulation

Intervention Type: DEVICE

Stimulation of the postural reflex arc to activate the soleus muscle during dialysis

Interventions

Calf Muscle Pump Stimulation

Stimulation of the postural reflex arc to activate the soleus muscle during dialysis

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Binghamton University

OTHER

Sponsor Role: lead

Responsible Party

Kenneth McLeod

Professor, BioEngineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth J. McLeod, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clinical Science and Engineering Research Center

Other Identifiers

521-07

Identifier Type: -

Identifier Source: org_study_id