The investigation is a prospective cohort study, where two patient groups will be monitored by a wearable bioimpedance sensor during their scheduled treatment. The overall objective is to assess the bioimpedance sensor's ability to detect local and systemic fluid accumulation. Sub-investigation A will investigate the ability of the device to detect fluid accumulation in patients with stable chronic kidney disease undergoing regular and planned hemodialysis. Sub-investigation B will investigate the ability of the device to track hydration status in patients scheduled for an "intensive" dialysis treatment regime, due to severe overhydration.
In Sub-investigation A, patients will be monitored for at least 10 consecutive dialysis sessions, and for a minimum of 3 weeks. Patients will wear two sensors (upper back and lower anterior leg). In Sub-investigation B, patients will use the device throughout their whole treatment period, and for most patients, this will correspond to 2-6 dialysis treatments over 3 to 10 days. Patients will wear four patches (upper back, lateral thorax, anterior thigh, and lower anterior leg).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid volume. It is designed as an adhesive patch with four integrated electrodes.
Rikshospitalet, Oslo University Hospital
Oslo, Norway
RECRUITINGUllevål sykehus, Oslo University Hospital
Oslo, Norway
RECRUITINGThe effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
Relative change in extracellular resistance of the upper back, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
Time frame: 1-4 days
The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients
Relative change in extracellular resistance of the lower anterior leg, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
Time frame: 1-4 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration
Relative change in extracellular resistance of the upper back, measured by the bioimpedance device from before to after the dialysis treatment regime in Sub-investigation B
Time frame: 2-10 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the lower anterior leg in patients with severe overhydration
Relative change in extracellular resistance of the lower anterior leg, measured by the bioimpedance device from before to after the dialysis treatment regime in Sub-investigation B
Time frame: 2-10 days
The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration
Relative change in extracellular resistance of the lateral thorax, measured by the bioimpedance device from before to after the dialysis treatment regime in Sub-investigation B
Time frame: 2-10 days
Safety of the investigational device
Frequency and severity of adverse device effects.
Time frame: Up to 4 weeks
The effect of an intensive dialysis treatment regime on the extracellular resistance of the anterior thigh
Relative change in extracellular resistance of the anterior thigh, measured by the bioimpedance device
Time frame: 2-10 days
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