Dehydration, Dialysis Related Complication
Conditions
Brief summary
This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.
Detailed description
The purpose is to test the sensitivity and specificity of a new electronic patch in the indication of the relative change in the fluid balance. If possible, the change in hydration level should be quantified. The test is done on patients during hemodialysis. Extracted amount of fluid is used as the primary reference to the bioimpedance measurements, but other references will also be used. The measurement is made using bioimpedance measured with four electrodes and over a large frequency spectrum. Impedance measurements are made every 20 seconds throughout the test period. The measurement is recorded in a memory (flash) on each patch. At the same time as measuring bioimpedance, the temperature in the patch is recorded. After completion of the test, the data is transferred to a computer for analysis. As a reference, extracted amount of fluid, weight change, blood samples and clinical evaluation are used.
Interventions
None listed
Sponsors
Helse Nord-Trøndelag HF
Mode Sensors AS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients for hemodialysis
Exclusion criteria
* Acute in-current disease. * Known adverse reaction to medical adhesive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of patch performance | August - December 2019 | Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results |
Countries
Norway
Contacts
Primary ContactJørn Kværness
Outcome results
None listed