E87.7 E86
Conditions
Interventions
Group 1: Objective of the Study
The aim of this clinical study is to evaluate a new measurement method that uses spectral data to determine tissue water content in patients. This method involves the t
Sponsors
Universitätsklinikum Ulm/Institut für Geriatrische Forschung c/o AGAPLESION Bethesda Klinik Ulm
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with edema or clinical hyperhydration, e.g., patients with right-sided cardiac decompensation (clinically assessed by medical personnel) - Patients with dehydration (clinically assessed by medical personnel)
Exclusion criteria
Exclusion criteria: - Patients unable to give consent (e.g. known advanced dementia) - Limited communication ability (e.g. due to lack of language proficiency) - Patients in palliative care (life expectancy <3 months based on clinical assessment by medical personnel)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T0-T6 (3x daily, morning, midday, evening) total body water content (%) determined by spectral measurement T0-T6 (morning): Clinical assessment of fluid balance T0, T3,T6, (morning): Laboratory analysis of serum osmolality T0, T3, T6 (morning): quantitative measurement of saliva osmolality T0, T3,T6, (morning ):Sonographic evaluation of intravascular volume status (width of the V. cava, respiratory variability) T0, T3,T6, (morning ): Determination of body composition using bioelectrical impedance analysis (BIA) | — |
Secondary
| Measure | Time frame |
|---|---|
| wearing comfort of the sensor | — |
Countries
Germany
Contacts
Public ContactMichael Denkinger
Institut für Geriatrische Forschung/ AGAPLESION Bethesda Klinik Ulm
Outcome results
None listed