Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

Not Applicable

Recruiting

• Conditions: Overhydration; Edema; Kidney Failure
• Interventions: Device: Wearable bioimpedance sensor

• Registration Number: NCT06053710
• Lead Sponsor: Mode Sensors AS

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 Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Study Start: 2023-11-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with severe overhydration	Wearable bioimpedance sensor	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).
Patients with chronic kidney failure	Wearable bioimpedance sensor	Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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 anterior thigh	2-10 days	Relative change in extracellular resistance of the anterior thigh, measured by the bioimpedance device

Trial Locations

Locations (2)

Rikshospitalet, Oslo University Hospital; 🇳🇴 Oslo, Norway

Ullevål sykehus, Oslo University Hospital; 🇳🇴 Oslo, Norway