Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis

Study Overview
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Brief Summary
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Cardiovascular disease is the leading cause of death of dialysis patients and poor fluid management is associated with the increased risk. One of the principal limitations in avoiding chronic fluid overload in this patient group is the refilling rate the rate at which fluid is transferred from tissues into the vascular system. If this rate cannot match the prescribed rate of fluid removal during dialysis the patient will end up with chronic fluid overload. 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.

Official Title
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Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis

Conditions
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Kidney Failure

Intervention / Treatment
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* Device: Intermittent pneumatic compression device
* Device: Neuromuscular electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of lower limb oedema as defined by pitting 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 18 years of age Less than 3 months dialysis vintage Presence of metal implants, amputations or the inability to be weighed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A: baseline - IPC<br>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. | Device: Intermittent pneumatic compression device<br>* Flowtron, Circulation Booster and Sports XL devices will be used.<br>Device: Neuromuscular electrical stimulation<br>* Flowtron, Circulation Booster and Sports XL devices will be used.<br>|
| Other: B: baseline - NMES<br>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. | Device: Intermittent pneumatic compression device<br>* Flowtron, Circulation Booster and Sports XL devices will be used.<br>Device: Neuromuscular electrical stimulation<br>* Flowtron, Circulation Booster and Sports XL devices will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Status (Body composition monitor measurement of fluid status) | Body composition monitor measurement of fluid statu | Weekly | 
| Quality of Life (Validated Kidney Disease Quality of Life (KDQOL36) quality of life measurement questionnaire and patient symptom questionnaire) | Validated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire | Weekly |