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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: baseline - IPC | Other | 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. |
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| B: baseline - NMES | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent pneumatic compression device | Device | Flowtron, Circulation Booster and Sports XL devices will be used. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Keane, MSc, CSci | Contact | 01132064119 | david.keane@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | LS9 7TF | United Kingdom |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Neuromuscular electrical stimulation | Device | Flowtron, Circulation Booster and Sports XL devices will be used. |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |