Dermal Profile Analysis Using the NMR-MOUSE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-05-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dialysis patients

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.

Group Type EXPERIMENTAL

Dermal nuclear magnetic resonance (NMR)-profile measurement

Intervention Type DEVICE

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

Healthy volunteers

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.

Group Type EXPERIMENTAL

Dermal nuclear magnetic resonance (NMR)-profile measurement

Intervention Type DEVICE

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

Interventions

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Dermal nuclear magnetic resonance (NMR)-profile measurement

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

Intervention Type DEVICE

Other Intervention Names

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NMR-MOUSE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes