Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes

NCT ID: NCT04937478

Last Updated: 2023-04-18

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

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2021-12-30

Brief Summary

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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).

Detailed Description

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Conditions

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Hemodialysis, Ultrafiltration, Bioimpedance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodialysis patients

Patients who undergo hemodialysis in hospital every two to three days.

Observation

Intervention Type OTHER

Only observational study, no intervention.

Interventions

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Observation

Only observational study, no intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for hemodialysis
* signed Informed Consent Form

Exclusion Criteria

* acute intercurrent disease,
* subjects with known hypersensitivity to plasters (adhesive or gel).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

Mode Sensors AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Levanger Hospital

Levanger, , Norway

Site Status

St Olavs university hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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CTR006 DELAGE 2

Identifier Type: -

Identifier Source: org_study_id

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