Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

Kidney Failure Clinical Trial

— DELOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053710
• Other study ID #: CTR0042A DELOS
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Mode Sensors AS
• Contact: Sigve N Aas, PhD
• Phone: 004741499074
• Email: sigve.aas[@]modesensors.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Kidney Failure
• Overhydration
• Renal Insufficiency
• Water Intoxication

Intervention

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.

Locations

Country	Name	City	State
Norway	Rikshospitalet, Oslo University Hospital	Oslo
Norway	Ullevål sykehus, Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Mode Sensors AS	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety of the investigational device	Frequency and severity of adverse device effects.	Up to 4 weeks
Secondary	The effect of an intensive dialysis treatment regime on the extracellular resistance of the anterior thigh	Relative change in extracellular resistance of the anterior thigh, measured by the bioimpedance device	2-10 days