NCT04937478

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

June 16, 2021

Last Update Submit

April 14, 2023

Conditions

Hemodialysis, Ultrafiltration, Bioimpedance

Outcome Measures

Primary Outcomes (1)

  • Correlation between ultrafiltered volume (UFV) and measured bioimpedance change

    A change in measured thoracic bioimpedance is expected to correlate to UFV

    During hemodialysis

Study Arms (1)

Hemodialysis patients

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

Other: Observation

Interventions

ObservationOTHER

Only observational study, no intervention.

Hemodialysis patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with hemodialysis for survival.

You may qualify if:

  • patients scheduled for hemodialysis
  • signed Informed Consent Form

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Levanger Hospital

Levanger, Norway

Location

St Olavs university hospital

Trondheim, 7030, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum: * osmolality * hemoglobin * platelets * sodium * potassium * creatinine * urea * glucose * magnesium * albumin

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 24, 2021

Study Start

April 20, 2021

Primary Completion

June 14, 2021

Study Completion

December 30, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared

Locations

NO(2)