Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor (DELOS)
Overhydration, Kidney Failure, Edema
About this trial
This is an interventional prevention trial for Overhydration focused on measuring Hydration
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Regular hemodialysis (≥ 2 times weekly) with ultrafiltration volume ≥ 1 liter (Sub-investigation A) Scheduled for intensive dialysis treatment due to severe overhydration (Sub-investigation B) Exclusion Criteria: Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out. Patients undergoing MRI Breached skin at patch mounting area Pregnancy Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Other
Other
Patients with chronic kidney failure
Patients with severe overhydration
Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks.
Patients with severe overhydration will wear bioimpedance sensors at the upper back, lateral thorax, and lower anterior leg throughout an intensive dialysis treatment regime (~2-10 days).