HemodialysisNCT07803029
Bioimpedance Spectroscopy (BIS): Fluid Changes in Hemodialysis Patients
A study testing Bioimpedance analysis in people with Hemodialysis, run by Per Ivarsen at 1 site in Denmark.
Trial summary
In connection with dialysis treatment, fluid and salt balance changes. Some kidney disease patients experience fluid accumulation in the body and need to have excess fluid removed via the dialysis machine. Others have too little fluid in their bodies and experience general symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Bioimpedance analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 11 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis for more than 3 month Hemodynamic stabile during a dialysis session
- -
Who cannot join
- Amputated limbs.
- Pregnant.
- Extremity palsy and paralysis.
- Implanted electronic device (e.g., pacemaker or ICD).
- Regular use of dialysate sodium proliferation.
- Hip, knee and shoulder prosthesis.
Show all 9Show fewer
- Dialysis fistula in both arms.
- Inability to give informed consent.
- History of discontinuation of dialysis treatment prematurely.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Denmark, 8200
Per Ivarsen, MD, +457845000, per.ivarsen@clin.au.dk
per.ivarsen@clin.au.dk
About this study
Official title: Bioimpedance Spectroscopy (BIS): Analysis of Changes in Fluid Status in Hemodialysis Patients
In connection with dialysis treatment, fluid and salt balance changes. Some kidney disease patients experience fluid accumulation in the body and need to have excess fluid removed via the dialysis machine. Others have too little fluid in their bodies and experience general symptoms. The amount of fluid that needs to be removed is an individual assessment and can be difficult to determine. Today, fluid removal is determined based on signs such as water in the lungs, swollen legs, and blood pressure. By using a so-called bioimpedance spectroscopy (BIS) device, it os possible measure how much fluid is in the body. However, the calculations that BIS devices use are developed for healthy individuals and do not work optimally during dialysis. Therefore, the investigators will use the actual measurements and compare them with fluid extraction and weight changes to examine their relationship. Hemodialysis patients with ultrafiltration on 3 consecutive dialysis days in order to investigate whether there is a difference in measurements after the long dialysis break and whether the measurements are the same when you are being drawn to your dry weight are included. Other patients without fluid removed during dialysis will be investigated once. I the study the absolute blood volume is also measured, that is, how much fluid is in the bloodstream. This is also an expression of the body's total fluid volume. By combining the various measurements, the study will gain increased knowledge about your hydration status. If the measurement methods have sufficient precision, the use of BIS and measurement of total blood volume may contribute to a more accurate determination of your dry weight.
Read the detailed description
To investigate whether raw impedance data from BIS measurements can be used as a tool to estimate changes in fluid status in HD patients. Accuracy is low when using prediction equations that are integrated into the individual BIS device. This challenges the application in clinical practice. Furthermore, the prediction equation is not available for most devices. Small studies suggest greater accuracy when using raw data, which could make BIS measurements clinically applicable. Detailed purpose. To examine whether raw impedance data from BIS measurements can be used as a tool to estimate changes in fluid status in HD patients.
- Ensure consistency in measurements of raw impedance data (Phase angle, RE, RI, R∞, and Cm) between different BIS devices (here: Fresenius BCM®, SFB7®, and SOZO® from ImpediMed).
- Compare intradialytic ∆RE, ∆R∞, and ∆Cm against changes in absolute blood volume, BP, weight, and fluid removal in HD patients with fluid removal.
- Is the phase angle consistent over the 3 dialysis days in a week for center dialysis patients with fluid retention?
- Compare intradialytic ∆RE, ∆R∞, and ∆Cm against changes in absolute blood volume, blood pressure, and weight in hemodialysis patients without fluid retention.
- Compare intradialytic ∆blood pressure, ∆weight, ∆ABV, fluid retention, and BIS measured changes (∆RE, ∆R∞, ∆Cm) for patients undergoing home hemodialysis with patients undergoing center hemodialysis.
- Conditions
- Hemodialysis
- Being tested
- Bioimpedance analysis
- Keywords
- hemodialysis, bioimpedance, absolute blood volume, total body water, extracellular body water, intracellular water, body weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance analysisDevice
Comparing the perfomance of original data from 3 different bioimpedance apparatur and test there precision and accurary compared to ultrafiltration. And whether the performance of measuring absolut blood volume is better
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patient | Active comparator | Measurement wil be donne before and after a hemodialysis. Bioimpendance spectroscopy is measured with 3 different bioimpedance apperatur. Absolute blood volumen is measured 5-10 minutes after starting and before stopping the dialysis session. For center hemodialysis patients with ultrafiltration measurement til be performed on 3 consecutive days and for patient center hemodialysis patient meaurement wil be performed once with also apply for Home hemodialysis patients. Receives: Device: Bioimpedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BIS measured resistance and fluid removed
To investigate whether raw impedance data from BIS measurements can be used as a tool to estimate changes in fluid status in HD patients before and after a hemodialysis session of 4 hours duration. Weight loss during a hemodialysis session is equivalent to fluid removed. The meausement are don for up to oen week
- To determine consistency in measurements of raw impedance data (Ω) between different BIS devices (here: Fresenius BCM ®, SFB7 ® and SOZO ® from Imped-iMed).
- Change in raw impedance data (Ω) during a hemodialysis session of 4 hours
- Degree of ultrafiltrating (ml) a hemodialysis session of 4 hours
- Change in absolute blood volume (ml) during a hemodialysis session of 4 hours
- In a subset of patients test if the length of the of pause (days) between hemodialysis session influence the raw impedance measurements.
Measured: From enrollment to the end of the dialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start11 May 2025
- Primary completion16 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Per Ivarsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Ivarsen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803029
- Sponsor's protocol ID
- VMK2500694
- Status last verified
- May 2026
- First submitted
- 3 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Spectroscopy (BIS): Analysis of Changes in Fluid Status in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07803029
- Acronym / sponsor ID
- VMK2500694
- Conditions
- Hemodialysis
- Keywords
- hemodialysis, bioimpedance, absolute blood volume, total body water, extracellular body water, intracellular water, body weight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Per IvarsenUniversity, hospital or other
- Study start
- 11 May 2025 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 2026 (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.
In connection with dialysis treatment, fluid and salt balance changes. Some kidney disease patients experience fluid accumulation in the body and need to have excess fluid removed via the dialysis machine. Others have too little fluid in their bodies and experience general symptoms. The amount of fluid that needs to be removed is an individual assessment and can be difficult to determine. Today, fluid removal is determined based on signs such as water in the lungs, swollen legs, and blood pressure. By using a so-called bioimpedance spectroscopy (BIS) device, it os possible measure how much fluid is in the body. However, the calculations that BIS devices use are developed for healthy individuals and do not work optimally during dialysis. Therefore, the investigators will use the actual measurements and compare them with fluid extraction and weight changes to examine their relationship. Hemodialysis patients with ultrafiltration on 3 consecutive dialysis days in order to investigate whether there is a difference in measurements after the long dialysis break and whether the measurements are the same when you are being drawn to your dry weight are included. Other patients without fluid removed during dialysis will be investigated once. I the study the absolute blood volume is also measured, that is, how much fluid is in the bloodstream. This is also an expression of the body's total fluid volume. By combining the various measurements, the study will gain increased knowledge about your hydration status. If the measurement methods have sufficient precision, the use of BIS and measurement of total blood volume may contribute to a more accurate determination of your dry weight.
Detailed description
To investigate whether raw impedance data from BIS measurements can be used as a tool to estimate changes in fluid status in HD patients. Accuracy is low when using prediction equations that are integrated into the individual BIS device. This challenges the application in clinical practice. Furthermore, the prediction equation is not available for most devices. Small studies suggest greater accuracy when using raw data, which could make BIS measurements clinically applicable. Detailed purpose. To examine whether raw impedance data from BIS measurements can be used as a tool to estimate changes in fluid status in HD patients.
- Ensure consistency in measurements of raw impedance data (Phase angle, RE, RI, R∞, and Cm) between different BIS devices (here: Fresenius BCM®, SFB7®, and SOZO® from ImpediMed).
- Compare intradialytic ∆RE, ∆R∞, and ∆Cm against changes in absolute blood volume, BP, weight, and fluid removal in HD patients with fluid removal.
- Is the phase angle consistent over the 3 dialysis days in a week for center dialysis patients with fluid retention?
- Compare intradialytic ∆RE, ∆R∞, and ∆Cm against changes in absolute blood volume, blood pressure, and weight in hemodialysis patients without fluid retention.
- Compare intradialytic ∆blood pressure, ∆weight, ∆ABV, fluid retention, and BIS measured changes (∆RE, ∆R∞, ∆Cm) for patients undergoing home hemodialysis with patients undergoing center hemodialysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patient | Active comparator | Device: Bioimpedance analysisMeasurement wil be donne before and after a hemodialysis. Bioimpendance spectroscopy is measured with 3 different bioimpedance apperatur. Absolute blood volumen is measured 5-10 minutes after starting and before stopping the dialysis session. For center hemodialysis patients with ultrafiltration measurement til be performed on 3 consecutive days and for patient center hemodialysis patient meaurement wil be performed once with also apply for Home hemodialysis patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemodialysis for more than 3 month Hemodynamic stabile during a dialysis session
- -
Key exclusion criteria (9 listed)
- Amputated limbs.
- Pregnant.
- Extremity palsy and paralysis.
- Implanted electronic device (e.g., pacemaker or ICD).
- Regular use of dialysate sodium proliferation.
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 |
|---|---|---|
| Bioimpedance analysisComparing the perfomance of original data from 3 different bioimpedance apparatur and test there precision and accurary compared to ultrafiltration. And whether the performance of measuring absolut blood volume is better | Device | Hemodialysis patient |
Primary outcome
Changes in BIS measured resistance and fluid removed
Time frame: From enrollment to the end of the dialysis session
To investigate whether raw impedance data from BIS measurements can be used as a tool to estimate changes in fluid status in HD patients before and after a hemodialysis session of 4 hours duration. Weight loss during a hemodialysis session is equivalent to fluid removed. The meausement are don for up to oen week 1. To determine consistency in measurements of raw impedance data (Ω) between different BIS devices (here: Fresenius BCM ®, SFB7 ® and SOZO ® from Imped-iMed). 2. Change in raw impedance data (Ω) during a hemodialysis session of 4 hours 3. Degree of ultrafiltrating (ml) a hemodialysis session of 4 hours 4. Change in absolute blood volume (ml) during a hemodialysis session of 4 hours 4) In a subset of patients test if the length of the of pause (days) between hemodialysis session influence the raw impedance measurements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioimpedance analysis in people with Hemodialysis, run by Per Ivarsen at 1 site in Denmark.
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 9 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per Ivarsen, MD (+457845000, per.ivarsen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BIS measured resistance and fluid removed (time frame: From enrollment to the end of the dialysis session). 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 3 Sep 2026.