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Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)

NCT01481311 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2012-10-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Seca GmbH & Co. Kg.

    lead INDUSTRY

Principal Investigators

  • Torsten Slowinski, Dr. · Charite University, Berlin, Germany

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481311 on ClinicalTrials.gov