NCT03990818

Continuous Registration of Bioimpedance During Hemodialysis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Mode Sensors AS · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dialysis Related Complication
• Dehydration

Timeline

• Start date: 2019-08-20
• Primary completion: 2019-09-30
• Completion: 2019-12-31
• First posted: 2019-06-19
• Last updated: 2019-09-23

Locations

1 site across 1 country: Norway