Disturbance; Balance, Fluid, Exposure to Magnetic Field, Hypotension During Dialysis
Conditions
Brief summary
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
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.
Interventions
DEVICEDermal nuclear magnetic resonance (NMR)-profile measurement
Nuclear magnetic resonance (NMR)-profile measurement of the dermis
Sponsors
Institute for Technical and Macromolecular Chemistry, RWTH Aachen University
RWTH Aachen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers | 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NMR-Mouse dermal measurement | 30 minutes | The overall number of participants with treatment-related adverse events during the study will be investigated. |
| Time needed for NMR-Mouse dermal measurement | 30 minutes | The overall time needed to measure each participant of the study will be documented. |
Countries
Germany
Outcome results
None listed