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Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04937478
Acronym
CTR006
Enrollment
31
Registered
2021-06-24
Start date
2021-04-20
Completion date
2021-12-30
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Ultrafiltration, Bioimpedance

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).

Interventions

OTHERObservation

Only observational study, no intervention.

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Helse Nord-Trøndelag HF
CollaboratorOTHER
Mode Sensors AS
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients scheduled for hemodialysis * signed Informed Consent Form

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between ultrafiltered volume (UFV) and measured bioimpedance changeDuring hemodialysisA change in measured thoracic bioimpedance is expected to correlate to UFV

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026