Edema, Kidney Pancreas Transplant, Kidney Transplant
Conditions
Keywords
IPC/TEDS, Geko device
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.
Interventions
DEVICEGeko device
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in edema | Within 30 days post-transplant | As measured by patient weight and leg diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 3 and 6 days after transplant | Patients will be asked to complete a questionnaire at these time points to assess their satisfaction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of diuretics | Within 30 days of transplant | Diuretic use wil be tracked for participants in each of the arms to assess wither there is a difference. |
Countries
Canada
Outcome results
None listed