Continuous Registration of Bioimpedance During Hemodialysis (DELAGE)

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

Study Overview

• Status: Unknown
• Conditions: Dehydration; Dialysis Related Complication

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.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Jørn Kværness; Phone Number: +4795089723; Email: jorn@modesensors.com

Study Locations

• Norway
  • Levanger, Norway
    • Recruiting
    • Levanger Hospital
    • Contact: Carl Platou; Email: carl.platou@helse-nordtrondelag.no
    • Principal Investigator: Solfrid Romundstad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients for hemodialysis

Description

Inclusion Criteria:

• Patients for hemodialysis

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mode Sensors AS
• Collaborators: Helse Nord-Trøndelag HF
• Investigators: Study Chair: Magnus Nordahl, Mode Sensors AS

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 2019 DELAGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No