Dermal Profile Analysis Using the NMR-MOUSE

RWTH Aachen University31 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

Dermal nuclear magnetic resonance (NMR)-profile measurementDEVICE

Nuclear magnetic resonance (NMR)-profile measurement of the dermis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of RWTH Aachen, Department of Medicine II

Aachen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.

Time frame: 30 minutes

Secondary Outcomes

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.

Time frame: 30 minutes

Time needed for NMR-Mouse dermal measurement

The overall time needed to measure each participant of the study will be documented.

Time frame: 30 minutes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.