- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02450474
Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis
Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Keane, MSc, CSci
- Phone Number: 01132064119
- Email: david.keane@nhs.net
Study Locations
-
-
-
Leeds, United Kingdom, LS9 7TF
- Recruiting
- Leeds Teaching Hospitals NHS Trust
-
Contact:
- David Keane, MSc, CSci
- Phone Number: 01132064119
- Email: david.keane@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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. |
Flowtron, Circulation Booster and Sports XL devices will be used.
Flowtron, Circulation Booster and Sports XL devices will be used.
|
Other: 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. |
Flowtron, Circulation Booster and Sports XL devices will be used.
Flowtron, Circulation Booster and Sports XL devices will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluid Status (Body composition monitor measurement of fluid status)
Time Frame: Weekly
|
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)
Time Frame: Weekly
|
Validated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire
|
Weekly
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL14/11224
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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