Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis
NCT ID: NCT02450474
Last Updated: 2015-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2014-02-28
2016-01-31
Brief Summary
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Two proposed methods of increasing the rate of refilling are intermittent pneumatic compression (IPC) devices, which increase the pressure of the fluid in tissue, and neuromuscular electrical stimulation (NMES) which activates the muscle pump and lymphatic drainage.
This investigation will trial the use of these two methods in patients suspected of having inadequate refilling rates. Outcome measures will be based on fluid status, presence of oedema and quality of life.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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A: baseline - IPC
A: baseline - IPC - washout - NMES - washout - follow up
The baseline phase, washout phase and follow up phase will consist of treatment as normal. IPC phase will consist of normal care plus IPC of the lower limbs for the duration of each dialysis session.
Intermittent pneumatic compression device
Flowtron, Circulation Booster and Sports XL devices will be used.
Neuromuscular electrical stimulation
Flowtron, Circulation Booster and Sports XL devices will be used.
B: baseline - NMES
B: baseline - NMES - washout - IPC - washout follow up
The baseline phase, washout phase and follow up phase will consist of treatment as normal. NMES phase will consist of normal care plus stimulation of the foot and calf muscles for a period of one hour during dialysis.
Intermittent pneumatic compression device
Flowtron, Circulation Booster and Sports XL devices will be used.
Neuromuscular electrical stimulation
Flowtron, Circulation Booster and Sports XL devices will be used.
Interventions
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Intermittent pneumatic compression device
Flowtron, Circulation Booster and Sports XL devices will be used.
Neuromuscular electrical stimulation
Flowtron, Circulation Booster and Sports XL devices will be used.
Eligibility Criteria
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Inclusion Criteria
* Average post dialysis fluid overload in relation to target weight greater than 0.5 litres
* Greater than one dialysis session that included an intradialytic hypotensive episode in the previous month, defined by saline influsion or nursing intervention
Exclusion Criteria
* Less than 3 months dialysis vintage
* Presence of metal implants, amputations or the inability to be weighed
18 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
The Leeds Teaching Hospitals NHS Trust
OTHER
Responsible Party
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Locations
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Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RL14/11224
Identifier Type: -
Identifier Source: org_study_id
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