Continuous Registration of Bioimpedance During Hemodialysis (DELAGE)

M

Mode Sensors

Status

Unknown

Conditions

Dialysis Related Complication
Dehydration

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03990818
2019 DELAGE

Details and patient eligibility

About

This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients for hemodialysis

Exclusion criteria

  • Acute in-current disease.
  • Known adverse reaction to medical adhesive

Trial contacts and locations

0

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Central trial contact

Jørn Kværness

Data sourced from clinicaltrials.gov

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