Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

Not Applicable

Recruiting

• Conditions: Overhydration; Edema; Kidney Failure

• 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

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