Clinical trial NCT06053710: Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor
Official title: Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overhydration
Kidney Failure
Edema
Keywords: Hydration
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
Collaborators: name: Oslo University Hospital
First posted: 2023-09-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
timeFrame: 1-4 days
Secondary outcomes:
measure: The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients
timeFrame: 1-4 days
measure: The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration
timeFrame: 2-10 days
measure: The effect of an intensive dialysis treatment regime on the extracellular resistance of the lower anterior leg in patients with severe overhydration
timeFrame: 2-10 days
measure: The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration
timeFrame: 2-10 days
measure: Safety of the investigational device
timeFrame: Up to 4 weeks
measure: The effect of an intensive dialysis treatment regime on the extracellular resistance of the anterior thigh
timeFrame: 2-10 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Oslo University Hospital
city: Oslo
country: Norway
facility: Ullevål sykehus, Oslo University Hospital
Study officials:
affiliation: Mode Sensors AS
name: Sigve N Aas, PhD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Nanna von der Lippe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Hege K Pihlstrøm, PhD
role: PRINCIPAL_INVESTIGATOR
References: