Dermal Profile Analysis Using the NMR-MOUSE

Study Overview
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Brief Summary
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The determination of fluid status in dialysis patients is a major clinical problem. In this study the NMR-MOUSE is used to determine if it can be used to non-invasively determine hydration status of the skin. This evaluation will be performed in dialysis patients and healthy volunteers.

Detailed Description
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Excretion of urine is impaired in terminal chronic kidney disease patients often requiring dialysis. Fluid management of dialysis patients is solely based on body weight differences before and after dialysis. Patients can suffer from either hypotension if too much fluid is eliminated by dialysis or from fluid-overload symptom (e.g. shortness of breath, edema) if not enough fluid is eliminated. In this study a mobile non-invasive NMR-MOUSE setup (a nuclear magnetic resonance spectroscopy measurement) is used to measure the hydration status of the skin.

Official Title
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Dermal Profile Analysis Using NMR-MOUSE (Nuclear Magnetic Resonance - Mobile Universal Surface Explorer)

Conditions
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Exposure to Magnetic Field, Hypotension During Dialysis, Disturbance; Balance, Fluid

Intervention / Treatment
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* Device: Dermal nuclear magnetic resonance (NMR)-profile measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Dialysis ability to perform NMR-measurement Eligibility to sign informed consent signed informed consent Exclusion Criteria: implanted cardiac device implanted cranial device implanted cochlea device intrauterine device other metallic implants tattoo, any skin disease or scars from surgery (in the area of measurement) previous skin treatment with cosmetics (of any kind) 24 hours prior to measurement wearing of earrings, piercings or hearings-aids during measurement participation in other clinical trials 30 days prior to participation in the SHN study no written informed consent any conditions, as determined by the examiner, that excludes the patient from participation in the study subjects with legal guardian pregnancy or lactation (a possible pregnancy of a participant before menopause will be excluded before inclusion in the study) subjects under employment or with any relation to the the sponsor or the investigator participation in any other study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialysis patients<br>In this group dialysis patients are measured by NMR-Mobile Universal Surface Explorer® (NMR-Mouse) during their routine dialysis sessions. After a 5 min rest period the arm of the patients is placed onto the NMR-Mouse and measured before the beginning of dialysis. The arm examined is not the shunt arm. The area selected should not display any signs of skin disease or scars from previous surgeries. After the dialysis the same area is measured again in a second measurement. The measurement will be repeated on three different days with each patient. | Device: Dermal nuclear magnetic resonance (NMR)-profile measurement<br>* Nuclear magnetic resonance (NMR)-profile measurement of the dermis<br>* Other names: NMR-MOUSE;|
| Experimental: Healthy volunteers<br>In this group kidney-healthy volunteers will be examined by NMR-Mobile Universal Surface Explorer® (NMR-Mouse) at three different days. The right/left arm or leg will be used for repeated measurement. Altogether 2 measurements per day are reformed in order to evaluate the reproducibility and variability. | Device: Dermal nuclear magnetic resonance (NMR)-profile measurement<br>* Nuclear magnetic resonance (NMR)-profile measurement of the dermis<br>* Other names: NMR-MOUSE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers | The skin will be subjected to a weak magnetic field (B0). The transversal relaxation time T2 [in s] will be measured stepwise in mm (millimeter) profiles for up to 16 mm depth in the skin. From the different measurements per profile of the skin a diffusion coefficient D [m²/s] will be calculated, which changes dependent on the hydration status of the skin. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NMR-Mouse dermal measurement | The overall number of participants with treatment-related adverse events during the study will be investigated. | 30 minutes | 
| Time needed for NMR-Mouse dermal measurement | The overall time needed to measure each participant of the study will be documented. | 30 minutes |