Bioimpedance Spectroscopy (BIS): Fluid Changes in Hemodialysis Patients

ConditionHemodialysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPer Ivarsen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Amputated limbs.

Pregnant.

Extremity palsy and paralysis.

Implanted electronic device (e.g., pacemaker or ICD).

Trial design

Design model

Single group

Treatments tested in this trial

  • Bioimpedance analysis

    Device

    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

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Hemodialysis patientActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 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.

Time frame
From enrollment to the end of the dialysis session

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Per Ivarsen

Lead sponsor

University of Aarhus

Sponsor institution