Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal nuclear magnetic resonance (NMR)-profile measurement | Device | Nuclear magnetic resonance (NMR)-profile measurement of the dermis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time needed for NMR-Mouse dermal measurement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jürgen Floege, M.D. | RWTH Aachen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of RWTH Aachen, Department of Medicine II | Aachen | North Rhine-Westphalia | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15975840 | Background | 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. | |
| 23290626 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The overall time needed to measure each participant of the study will be documented. |
| 30 minutes |
| 16580238 | 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. |
| 20404719 | 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. |
| 15611362 | 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. |