Dermal Profile Analysis Using NMR-MOUSE (Nuclear Magnetic Resonance - Mobile Universal Surface Explorer)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80
- •ability to perform NMR-measurement
- •Eligibility to sign informed consent
- •signed informed consent
排除标准
- •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
结局指标
主要结局
Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers
时间窗: 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.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NMR-Mouse dermal measurement(30 minutes)
- Time needed for NMR-Mouse dermal measurement(30 minutes)