Trials / Completed
CompletedNCT01481311
Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 62 (actual)
- Sponsor
- Seca GmbH & Co. Kg. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this clinical investigation is to prove that the seca mbca detects dialysis patients with abnormal water distribution correctly. Abnormal high water distribution is defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method should be evaluated to the accuracy of the absolute measurement of the volume state of dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | medical Body Composition Analyzer seca 514/515 | Current of 100 µA |
| PROCEDURE | Deuterium and Sodium Bromide dilution methods | Orally administered to the subject in a solution with 100 ml tap water. |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2011-11-29
- Last updated
- 2012-10-03
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01481311. Inclusion in this directory is not an endorsement.