Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes

Completed

• Conditions: Hemodialysis, Ultrafiltration, Bioimpedance
• Interventions: Other: Observation

• Registration Number: NCT04937478
• Lead Sponsor: Mode Sensors AS

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-04-20
• Primary Completion: 2021-06-14
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-24
• Study Completion: 2021-12-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysis patients	Observation	Patients who undergo hemodialysis in hospital every two to three days.

Primary Outcome Measures

Name	Time	Method
Correlation between ultrafiltered volume (UFV) and measured bioimpedance change	During hemodialysis	A change in measured thoracic bioimpedance is expected to correlate to UFV

Trial Locations

Locations (2)

Levanger Hospital; 🇳🇴 Levanger, Norway

St Olavs university hospital; 🇳🇴 Trondheim, Norway