Dermal Profile Analysis Using the NMR-MOUSE

Hypotension During Dialysis Clinical Trial

— SHN  

Official title:

Dermal Profile Analysis Using NMR-MOUSE (Nuclear Magnetic Resonance - Mobile Universal Surface Explorer)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02934009
• Other study ID #: 11-014
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 8, 2020

Study information

• Verified date: March 2021
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Dermal nuclear magnetic resonance (NMR)-profile measurement
Nuclear magnetic resonance (NMR)-profile measurement of the dermis

Locations

Country	Name	City	State
Germany	University Hospital of RWTH Aachen, Department of Medicine II	Aachen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	Institute for Technical and Macromolecular Chemistry, RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Danieli E, Blümich 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. Review. — View 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. — View Citation

Perlo J, Casanova F, Blümich B. Profiles with microscopic resolution by single-sided NMR. J Magn Reson. 2005 Sep;176(1):64-70. — View Citation

Perlo J, Casanova F, Blümich B. Single-sided sensor for high-resolution NMR spectroscopy. J Magn Reson. 2006 Jun;180(2):274-9. Epub 2006 Mar 31. — View 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. Epub 2004 Dec 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes
Secondary	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.	30 minutes
Secondary	Time needed for NMR-Mouse dermal measurement	The overall time needed to measure each participant of the study will be documented.	30 minutes