Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis

The Leeds Teaching Hospitals NHS Trust

Status: Unknown

Conditions: Kidney Failure

Treatments: Device: Intermittent pneumatic compression device; Device: Neuromuscular electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02450474

RL14/11224

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

A: baseline - IPC

Other group

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.

Treatment:

Device: Neuromuscular electrical stimulation

Device: Intermittent pneumatic compression device

B: baseline - NMES

Other group

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.

Treatment:

Device: Neuromuscular electrical stimulation

Device: Intermittent pneumatic compression device