Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis

Not Applicable

• Conditions: Kidney Failure
• Interventions: Device: Intermittent pneumatic compression device; Device: Neuromuscular electrical stimulation

• Registration Number: NCT02450474
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-12-16
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-18
• Last Update Submitted: 2015-05-18
• Study First Posted: 2015-05-21
• Last Update Posted: 2015-05-21
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: baseline - IPC	Neuromuscular electrical stimulation	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	Neuromuscular electrical stimulation	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.
A: baseline - IPC	Intermittent pneumatic compression device	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	Intermittent pneumatic compression device	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.

Primary Outcome Measures

Name	Time	Method
Fluid Status (Body composition monitor measurement of fluid status)	Weekly	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)	Weekly	Validated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire

Trial Locations

Locations (1)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom