Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mode Sensors AS
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with chronic kidney failure
Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks.
Intervention: Wearable bioimpedance sensor (Device)
Patients with severe overhydration
Patients with severe overhydration will wear bioimpedance sensors at the upper back, lateral thorax, anterior thigh, and lower anterior leg throughout an intensive dialysis treatment regime (~2-10 days).
Intervention: Wearable bioimpedance sensor (Device)
Outcomes
Primary Outcomes
The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
Time Frame: 1-4 days
Relative change in extracellular resistance of the upper back, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
Secondary Outcomes
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration(2-10 days)
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the anterior thigh(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(2-10 days)
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration(2-10 days)
- Safety of the investigational device(Up to 4 weeks)
- The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients(1-4 days)