DELOS: Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 three patches (upper back, lateral thorax, and lower anterior leg).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Device: Wearable bioimpedance sensor
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.
|
| Other: Patients with severe overhydration 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
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.
|
Outcome Measures
Primary Outcome Measures
- The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients [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 Outcome Measures
- The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients [1-4 days]
Relative change in extracellular resistance of the lower anterior leg, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration [2-10 days]
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
- 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]
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
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration [2-10 days]
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
- Safety of the investigational device [Up to 4 weeks]
Frequency and severity of adverse device effects.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Regular hemodialysis (≥ 2 times weekly) with ultrafiltration volume ≥ 1 liter (Sub-investigation A)
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Scheduled for intensive dialysis treatment due to severe overhydration (Sub-investigation B)
Exclusion Criteria:
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Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
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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.
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Patients undergoing MRI
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Breached skin at patch mounting area
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Pregnancy
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Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mode Sensors AS
- Oslo University Hospital
Investigators
- Study Director: Sigve N Aas, PhD, Mode Sensors AS
- Principal Investigator: Nanna von der Lippe, PhD, Oslo University Hospital
- Principal Investigator: Hege K Pihlstrøm, PhD, Oslo University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTR0042A DELOS