Dermal Profile Analysis Using the NMR-MOUSE (SHN)

RWTH Aachen University

Status: Terminated

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

Treatments: Device: Dermal nuclear magnetic resonance (NMR)-profile measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02934009

11-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Dialysis patients

Experimental group

Description:

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.

Treatment:

Device: Dermal nuclear magnetic resonance (NMR)-profile measurement

Healthy volunteers

Experimental group

Description:

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.

Treatment:

Device: Dermal nuclear magnetic resonance (NMR)-profile measurement