NCT02450474

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

December 16, 2014

Last Update Submit

May 18, 2015

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (2)

  • Fluid Status (Body composition monitor measurement of fluid status)

    Body composition monitor measurement of fluid statu

    Weekly

  • 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

    Weekly

Study Arms (2)

A: baseline - IPC

OTHER

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.

Device: Intermittent pneumatic compression deviceDevice: Neuromuscular electrical stimulation

B: baseline - NMES

OTHER

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.

Device: Intermittent pneumatic compression deviceDevice: Neuromuscular electrical stimulation

Interventions

Intermittent pneumatic compression deviceDEVICE

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

A: baseline - IPCB: baseline - NMES
Neuromuscular electrical stimulationDEVICE

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

A: baseline - IPCB: baseline - NMES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Less than 18 years of age
  • Less than 3 months dialysis vintage
  • Presence of metal implants, amputations or the inability to be weighed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

David Keane, MSc, CSci

CONTACT

01132064119david.keane@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

May 21, 2015

Study Start

February 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

GB(1)