Edema, Kidney Failure, Overhydration
Conditions
Keywords
Hydration
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).
Interventions
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.
Sponsors
Oslo University Hospital
Mode Sensors AS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| Safety of the investigational device | Up to 4 weeks | Frequency and severity of adverse device effects. |
| 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 |
| 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 |
Countries
Norway
Contacts
Primary ContactSigve N Aas, PhD
Backup ContactFrida Bremnes, M.Sc.
Outcome results
None listed