NCT07803029 Bioimpedance Spectroscopy (BIS): Fluid Changes in Hemodialysis Patients
| NCT ID | NCT07803029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Per Ivarsen |
| Condition | Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-05-11 |
| Primary Completion | 2026-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-05-11 with a primary completion date of 2026-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: Hemodialysis for more than 3 month Hemodynamic stabile during a dialysis session \- Exclusion Criteria: 1. Amputated limbs. 2. Pregnant. 3. Extremity palsy and paralysis. 4. Implanted electronic device (e.g., pacemaker or ICD). 5. Regular use of dialysate sodium proliferation. 6. Hip, knee and shoulder prosthesis. 7. Dialysis fistula in both arms. 8. Inability to give informed consent. 9. History of discontinuation of dialysis treatment prematurely.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07803029 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07803029 currently recruiting?
Yes, NCT07803029 is actively recruiting participants. Contact the research team at per.ivarsen@clin.au.dk for enrollment information.
Where is the NCT07803029 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT07803029 clinical trial?
NCT07803029 is sponsored by Per Ivarsen. The trial plans to enroll 42 participants.