Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis
Primary Purpose
Kidney Failure
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intermittent pneumatic compression device
Neuromuscular electrical stimulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Kidney Failure
Eligibility Criteria
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
Sites / Locations
- Leeds Teaching Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
A: baseline - IPC
B: baseline - NMES
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Fluid Status (Body composition monitor measurement of fluid status)
Body composition monitor measurement of fluid statu
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02450474
First Posted
December 16, 2014
Last Updated
May 18, 2015
Sponsor
The Leeds Teaching Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT02450474
Brief Title
Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis
Official Title
Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A: baseline - IPC
Arm Type
Other
Arm Description
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.
Arm Title
B: baseline - NMES
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intermittent pneumatic compression device
Intervention Description
Flowtron, Circulation Booster and Sports XL devices will be used.
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
Flowtron, Circulation Booster and Sports XL devices will be used.
Primary Outcome Measure Information:
Title
Fluid Status (Body composition monitor measurement of fluid status)
Description
Body composition monitor measurement of fluid statu
Time Frame
Weekly
Title
Quality of Life (Validated Kidney Disease Quality of Life (KDQOL36) quality of life measurement questionnaire and patient symptom questionnaire)
Description
Validated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire
Time Frame
Weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Keane, MSc, CSci
Phone
01132064119
Email
david.keane@nhs.net
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Keane, MSc, CSci
Phone
01132064119
Email
david.keane@nhs.net
12. IPD Sharing Statement
Learn more about this trial
Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis
We'll reach out to this number within 24 hrs