Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes (CTR006)

April 14, 2023 updated by: Mode Sensors AS

Correlation of Ultrafiltered Volume (UFV) During Hemodialysis With a New Battery Powered, Body Worn Electronic Patch Measuring Bioimpedance.

Patient submitted to hemodialysis are followed through a dialysis - interim - dialysis cycle.

No intervention is done. Additional blood tests and clinical tests are used as pseudo-endpoints. Correlation is made to ultrafiltrated volume (UFV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Levanger, Norway
        • Levanger Hospital
      • Trondheim, Norway, 7030
        • St Olavs University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with hemodialysis for survival.

Description

Inclusion Criteria:

  • patients scheduled for hemodialysis
  • signed Informed Consent Form

Exclusion Criteria:

  • acute intercurrent disease,
  • subjects with known hypersensitivity to plasters (adhesive or gel).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemodialysis patients
Patients who undergo hemodialysis in hospital every two to three days.
Other: Observation
Only observational study, no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between ultrafiltered volume (UFV) and measured bioimpedance change
Time Frame: During hemodialysis
A change in measured thoracic bioimpedance is expected to correlate to UFV
During hemodialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mode Sensors AS

Collaborators

St. Olavs Hospital
Helse Nord-Trøndelag HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Actual)

June 14, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CTR006 DELAGE 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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