Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor (DELOS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Edema; Kidney Failure; Overhydration
• Intervention / Treatment: Device: Wearable bioimpedance sensor

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigve N Aas, PhD; Phone Number: 004741499074; Email: sigve.aas@modesensors.com
• Study Contact Backup: Name: Frida Bremnes, M.Sc.; Email: frida.bremnes@modesensors.com

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Rikshospitalet, Oslo University Hospital
    • Contact: Hege K Pihlstrøm, PhD
  • Oslo, Norway
    • Recruiting
    • Ullevål sykehus, Oslo University Hospital
    • Contact: Nanna von der Lippe, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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, anterior thigh, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Safety of the investigational device	Frequency and severity of adverse device effects.	Up to 4 weeks
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

Collaborators and Investigators

• Sponsor: Mode Sensors AS
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hydration
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Water-Electrolyte Imbalance; Poisoning; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Water Intoxication
• Other Study ID Numbers: CTR0042A DELOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No