Continuous Registration of Bioimpedance During Hemodialysis

Dehydration Clinical Trial

— DELAGE  

Official title:

Continuous Registration of Bioimpedance During Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990818
• Other study ID #: 2019 DELAGE
• Status: Recruiting
• Start date: August 20, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: Mode Sensors AS
• Contact: Jørn Kværness
• Phone: +4795089723
• Email: jorn[@]modesensors.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients for hemodialysis

Exclusion Criteria:

• Acute in-current disease.

• Known adverse reaction to medical adhesive

Related Conditions & MeSH terms

• Dehydration
• Dialysis Related Complication

Locations

Country	Name	City	State
Norway	Levanger Hospital	Levanger

Sponsors (2)

Lead Sponsor	Collaborator
Mode Sensors AS	Levanger Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of patch performance	Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results	August - December 2019