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

Hypotension Clinical Trial

Official title:

the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00822653
• Other study ID #: 521-07
• Status: Withdrawn
• Phase: N/A
• First received: January 13, 2009
• Last updated: September 22, 2016
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: September 2016
• Source: Binghamton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• Calf Muscle Pump Stimulation
Stimulation of the postural reflex arc to activate the soleus muscle during dialysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Binghamton University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of ultrafiltration goal	Fraction of dialysis treatments where microfiltration target was achieved during 6 week period	6 weeks	No
Secondary	Hypotensive events	Number of hypotensive events experienced during dialysis over six week time period	6 weeks	No