Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

Study Overview
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Brief Summary
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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
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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 three patches (upper back, lateral thorax, and lower anterior leg).

Official Title
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Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)

Conditions
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Overhydration, Kidney Failure, Edema

Intervention / Treatment
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* Device: Wearable bioimpedance sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with chronic kidney failure<br>Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks. | Device: Wearable bioimpedance sensor<br>* 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.<br>|
| Other: Patients with severe overhydration<br>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). | Device: Wearable bioimpedance sensor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 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 | 1-4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 2-10 days | 
| Safety of the investigational device | Frequency and severity of adverse device effects. | Up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydration