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

NCT00822653 | Withdrawn

• 1 other identifier: 521-07
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypotension

Keywords

hemodialysis treatment; pump stimulation; reduce hypotensive episodes

Outcome Measures

Primary Outcomes (1)

• Achievement of ultrafiltration goal

  Fraction of dialysis treatments where microfiltration target was achieved during 6 week period

  6 weeks

Secondary Outcomes (1)

• Hypotensive events

  6 weeks

Study Arms (1)

Calf Muscle Pump Stimulation

EXPERIMENTAL

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

Interventions

Calf Muscle Pump Stimulation DEVICE

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

Calf Muscle Pump Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Binghamton University: lead

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kenneth J. McLeod, Ph.D.

  Clinical Science and Engineering Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, BioEngineering

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share