HypotensionNCT00822653
The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis
A study testing Calf Muscle Pump Stimulation in people with Hypotension, run by Binghamton University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Calf Muscle Pump Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Calf Muscle Pump Stimulation
- Keywords
- hemodialysis treatment, pump stimulation, reduce hypotensive episodes
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calf Muscle Pump StimulationDevice
Stimulation of the postural reflex arc to activate the soleus muscle during dialysis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Calf Muscle Pump Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of ultrafiltration goal
Fraction of dialysis treatments where microfiltration target was achieved during 6 week period
Measured: 6 weeks
Secondary outcomes (1)
Hypotensive events
Number of hypotensive events experienced during dialysis over six week time period
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Original principal investigator left the university before enrollment started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth McLeod, Binghamton University
- Investigators
- Kenneth J. McLeod, Ph.D., Principal investigator, Clinical Science and Engineering Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822653
- Sponsor's protocol ID
- 521-07
- Status last verified
- Sep 2016
- First submitted
- 13 Jan 2009
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Team is willing to share anonymous data with interested investigators
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life
- ClinicalTrials.gov ID
- NCT00822653
- Acronym / sponsor ID
- 521-07
- Conditions
- Hypotension
- Keywords
- hemodialysis treatment, pump stimulation, reduce hypotensive episodes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Original principal investigator left the university before enrollment started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calf Muscle Pump Stimulation | Experimental | Device: Calf Muscle Pump StimulationSubjects serve as self-control. Six weeks of dialysis data without intervention will be compared to six weeks post intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calf Muscle Pump StimulationStimulation of the postural reflex arc to activate the soleus muscle during dialysis | Device | Calf Muscle Pump Stimulation |
Primary outcome
Achievement of ultrafiltration goal
Time frame: 6 weeks
Fraction of dialysis treatments where microfiltration target was achieved during 6 week period
1 secondary outcome
Hypotensive events
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Individual participant dataSharing planned: Yes. Team is willing to share anonymous data with interested investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth J. McLeod, Ph.D. principal investigator
Clinical Science and Engineering Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Calf Muscle Pump Stimulation in people with Hypotension, run by Binghamton University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of ultrafiltration goal (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.