Hemodialysis, Ultrafiltration, BioimpedanceCTR006NCT04937478
Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes
An observational study of Hemodialysis, Ultrafiltration, Bioimpedance, run by Mode Sensors AS at 2 sites in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodialysis, Ultrafiltration, Bioimpedance
- What is being tested?
- Observation
- How many people
- 31 participants
- Where
- 2 sitesNorway
- Study dates
- 20 Apr 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with hemodialysis for survival.
Who may be able to join
- patients scheduled for hemodialysis
- signed Informed Consent Form
Who cannot join
- acute intercurrent disease,
- subjects with known hypersensitivity to plasters (adhesive or gel).
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Levanger Hospital
Levanger
St Olavs university hospital
Trondheim, 7030
About this study
Official title: 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).
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Only observational study, no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Patients who undergo hemodialysis in hospital every two to three days. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ultrafiltered volume (UFV) and measured bioimpedance change
A change in measured thoracic bioimpedance is expected to correlate to UFV
Measured: During hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start20 Apr 2021
- Primary completion14 Jun 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis, Ultrafiltration, BioimpedanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937478
- Sponsor's protocol ID
- CTR006 DELAGE 2
- Acronym
- CTR006
- Status last verified
- Apr 2023
- First submitted
- 16 Jun 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Ultrafiltered Volume (UFV) During Hemodialysis With a New Battery Powered, Body Worn Electronic Patch Measuring Bioimpedance.
- ClinicalTrials.gov ID
- NCT04937478
- Acronym / sponsor ID
- CTR006 / CTR006 DELAGE 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Other: ObservationPatients who undergo hemodialysis in hospital every two to three days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with hemodialysis for survival.
Key inclusion criteria (2 listed)
- patients scheduled for hemodialysis
- signed Informed Consent Form
Key exclusion criteria (2 listed)
- acute intercurrent disease,
- subjects with known hypersensitivity to plasters (adhesive or gel).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationOnly observational study, no intervention. | Other | Hemodialysis patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, Ultrafiltration, Bioimpedance, run by Mode Sensors AS at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ultrafiltered volume (UFV) and measured bioimpedance change (time frame: During hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.