Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis

NCT ID: NCT02450474

Last Updated: 2015-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Intermittent pneumatic compression device

Intervention Type DEVICE

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

Neuromuscular electrical stimulation

Intervention Type DEVICE

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

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.

Group Type OTHER

Intermittent pneumatic compression device

Intervention Type DEVICE

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

Neuromuscular electrical stimulation

Intervention Type DEVICE

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

Interventions

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Intermittent pneumatic compression device

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

Intervention Type DEVICE

Neuromuscular electrical stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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David Keane, MSc, CSci

Role: CONTACT

01132064119

Facility Contacts

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David Keane, MSc, CSci

Role: primary

01132064119

Other Identifiers

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RL14/11224

Identifier Type: -

Identifier Source: org_study_id

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