Clinical trial NCT01860820: The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
Official title: The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Kidney Pancreas Transplant
Edema
Keywords: IPC/TEDS
Geko device
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Detailed description: This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Male or female
* At least 18 years old
* Undergoing kidney or kidney pancreas transplant surgery as the recipient
* Able and willing to provide written informed consent
* Absence of known peripheral vascular disease
* Body Mass Index of between 18 and 34
* Leg circumference at site of geko™ device placement is 24" or less

Exclusion Criteria:

* History of deep vein thrombosis
* Temporary or permanent cardiac pacing
* Patient is pregnant
* Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
* Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
* Previous leg(s) amputation
* Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
* History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
* BMI index \>36
* Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
* History of implantable brain or other stimulator
* Patients who can not tolerate the stimulation from the GEKO device

Primary outcomes:
measure: Decrease in edema
timeFrame: Within 30 days post-transplant
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 and 6 days after transplant
Other outcomes:
measure: Use of diuretics
timeFrame: Within 30 days of transplant
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
Study officials:
affiliation: Lawson Health Research Institute, London Health Sciences Centre
name: Alp Sener, MD
role: PRINCIPAL_INVESTIGATOR
References: