Dermal Profile Analysis Using the NMR-MOUSE

NCT02934009 | Terminated

• 1 other identifier: 11-014
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Dialysis patients

EXPERIMENTAL

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.

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

Healthy volunteers

EXPERIMENTAL

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.

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

Interventions

Dermal nuclear magnetic resonance (NMR)-profile measurement DEVICE

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

Also known as: NMR-MOUSE

Dialysis patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Dialysis
• ability to perform NMR-measurement
• Eligibility to sign informed consent
• signed informed consent

You may not qualify if:

• 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
• subjects under employment or with any relation to the the sponsor or the investigator
• participation in any other study

Sponsors & Collaborators

• RWTH Aachen University: lead
• Institute for Technical and Macromolecular Chemistry, RWTH Aachen University: collaborator

Study Sites (1)

University Hospital of RWTH Aachen, Department of Medicine II

Aachen, North Rhine-Westphalia, Germany

Location

Related Publications (5)

• 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.

  PMID: 15975840 BACKGROUND

• 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.

  PMID: 23290626 BACKGROUND

• 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.

  PMID: 16580238 BACKGROUND

• 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.

  PMID: 20404719 BACKGROUND

• 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.

  PMID: 15611362 BACKGROUND

Study Officials

• Jürgen Floege, M.D.

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)