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.

Study Overview

• Status: Withdrawn
• Conditions: Hypotension
• Intervention / Treatment: Device: Calf Muscle Pump Stimulation

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Calf Muscle Pump Stimulation; Stimulation of the postural reflex arc to activate the soleus muscle during dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of ultrafiltration goal	Fraction of dialysis treatments where microfiltration target was achieved during 6 week period	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotensive events	Number of hypotensive events experienced during dialysis over six week time period	6 weeks

Collaborators and Investigators

• Sponsor: Binghamton University
• Investigators: Principal Investigator: Kenneth J. McLeod, Ph.D., Clinical Science and Engineering Research Center

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (ESTIMATE): January 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: hemodialysis treatment; pump stimulation; reduce hypotensive episodes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 521-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Team is willing to share anonymous data with interested investigators