ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02450474
Recruitment Status : Unknown
Verified May 2015 by The Leeds Teaching Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Kidney Failure Device: Intermittent pneumatic compression device Device: Neuromuscular electrical stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis
Study Start Date : February 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Arm Intervention/treatment
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.

Device: Intermittent pneumatic compression device
Flowtron, Circulation Booster and Sports XL devices will be used.

Device: Neuromuscular electrical stimulation
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.

Device: Intermittent pneumatic compression device
Flowtron, Circulation Booster and Sports XL devices will be used.

Device: Neuromuscular electrical stimulation
Flowtron, Circulation Booster and Sports XL devices will be used.




Primary Outcome Measures :
  1. Fluid Status (Body composition monitor measurement of fluid status) [ Time Frame: Weekly ]
    Body composition monitor measurement of fluid statu

  2. Quality of Life (Validated Kidney Disease Quality of Life (KDQOL36) quality of life measurement questionnaire and patient symptom questionnaire) [ Time Frame: Weekly ]
    Validated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450474


Contacts
Contact: David Keane, MSc, CSci 01132064119 david.keane@nhs.net

Locations
United Kingdom
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: David Keane, MSc, CSci    01132064119    david.keane@nhs.net   
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
National Institute for Health Research, United Kingdom

Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02450474     History of Changes
Other Study ID Numbers: RL14/11224
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases