Clinical trial NCT02934009: Dermal Profile Analysis Using the NMR-MOUSE
Official title: Dermal Profile Analysis Using NMR-MOUSE (Nuclear Magnetic Resonance - Mobile Universal Surface Explorer)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Exposure to Magnetic Field
Hypotension During Dialysis
Disturbance; Balance, Fluid
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Institute for Technical and Macromolecular Chemistry, RWTH Aachen University
First posted: 2016-10-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers
timeFrame: 30 minutes
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NMR-Mouse dermal measurement
timeFrame: 30 minutes
measure: Time needed for NMR-Mouse dermal measurement
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital of RWTH Aachen, Department of Medicine II
state: NRW
Study officials:
affiliation: RWTH Aachen University
name: Jürgen Floege, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perlo J, Casanova F, Blumich B. Profiles with microscopic resolution by single-sided NMR. J Magn Reson. 2005 Sep;176(1):64-70. doi: 10.1016/j.jmr.2005.05.017.
citation: Danieli E, Blumich B. Single-sided magnetic resonance profiling in biological and materials science. J Magn Reson. 2013 Apr;229:142-54. doi: 10.1016/j.jmr.2012.11.023. Epub 2012 Dec 8.
citation: Perlo J, Casanova F, Blumich B. Single-sided sensor for high-resolution NMR spectroscopy. J Magn Reson. 2006 Jun;180(2):274-9. doi: 10.1016/j.jmr.2006.03.004. Epub 2006 Mar 31.
citation: Medrano G, Eitner F, Floege J, Leonhardt S. A novel bioimpedance technique to monitor fluid volume state during hemodialysis treatment. ASAIO J. 2010 May-Jun;56(3):215-20. doi: 10.1097/MAT.0b013e3181d89160.
citation: Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20.