Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor — DELOS  

Kidney Failure Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT06053710
• Study type: Interventional
• Source: Mode Sensors AS
• Contact: Sigve N Aas, PhD
• Phone: 004741499074
• Email: sigve.aas@modesensors.com
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Completion date: December 31, 2024