Continuous Registration of Bioimpedance During Hemodialysis

NCT ID: NCT03990818

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-20

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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

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Dialysis Related Complication Dehydration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients for hemodialysis

Exclusion Criteria

* Acute in-current disease.
* Known adverse reaction to medical adhesive
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

Mode Sensors AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magnus Nordahl

Role: STUDY_CHAIR

Mode Sensors AS

Locations

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Levanger Hospital

Levanger, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Jørn Kværness

Role: CONTACT

+4795089723

Facility Contacts

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Carl Platou

Role: primary

Other Identifiers

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2019 DELAGE

Identifier Type: -

Identifier Source: org_study_id

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