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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic kidney failure | Other | Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks. |
|
| Patients with severe overhydration | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable bioimpedance sensor | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sigve N Aas, PhD | Contact | 004741499074 | sigve.aas@modesensors.com | |
| Frida Bremnes, M.Sc. | Contact | frida.bremnes@modesensors.com |
| Name | Affiliation | Role |
|---|---|---|
| Sigve N Aas, PhD | Mode Sensors AS | Study Director |
| Nanna von der Lippe, PhD | Oslo University Hospital | Principal Investigator |
| Hege K Pihlstrøm, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rikshospitalet, Oslo University Hospital | Recruiting | Oslo | Norway |
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| ID | Term |
|---|---|
| D014869 | Water Intoxication |
| D051437 | Renal Insufficiency |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011041 | Poisoning |
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| 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 |
| Oslo University Hospital |
| Principal Investigator |
| Ullevål sykehus, Oslo University Hospital | Recruiting | Oslo | Norway |
|
| D064419 | Chemically-Induced Disorders |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |