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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02450474
Enrollment
12
Registered
2015-05-21
Start date
2014-02-28
Completion date
2016-01-31
Last updated
2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

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.

Interventions

DEVICEIntermittent pneumatic compression device

Flowtron, Circulation Booster and Sports XL devices will be used.

DEVICENeuromuscular electrical stimulation

Flowtron, Circulation Booster and Sports XL devices will be used.

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fluid Status (Body composition monitor measurement of fluid status)WeeklyBody 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)WeeklyValidated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire

Countries

United Kingdom

Contacts

Primary ContactDavid Keane, MSc, CSci
david.keane@nhs.net01132064119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026