Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis

Kidney Failure Clinical Trial

Official title:

Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450474
• Other study ID #: RL14/11224
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2014
• Last updated: May 18, 2015
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2015
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: David Keane, MSc, CSci
• Phone: 01132064119
• Email: david.keane[@]nhs.net
• Is FDA regulated: No
• Health authority: Health Research Authority: UK
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid Status (Body composition monitor measurement of fluid status)	Body composition monitor measurement of fluid statu	Weekly	No
Primary	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	No