Kidney Failure Clinical Trial
— DELOSOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Rikshospitalet, Oslo University Hospital | Oslo | |
Norway | Ullevål sykehus, Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Mode Sensors AS | Oslo University Hospital |
Norway,
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 |
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