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

NCT ID: NCT01481311

Last Updated: 2012-10-03

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

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients before dialysis treatment

medical Body Composition Analyzer seca 514/515

Intervention Type DEVICE

Current of 100 µA

Deuterium and Sodium Bromide dilution methods

Intervention Type PROCEDURE

Orally administered to the subject in a solution with 100 ml tap water.

Patients after dialysis treatment

medical Body Composition Analyzer seca 514/515

Intervention Type DEVICE

Current of 100 µA

Deuterium and Sodium Bromide dilution methods

Intervention Type PROCEDURE

Orally administered to the subject in a solution with 100 ml tap water.

Interventions

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medical Body Composition Analyzer seca 514/515

Current of 100 µA

Intervention Type DEVICE

Deuterium and Sodium Bromide dilution methods

Orally administered to the subject in a solution with 100 ml tap water.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

The study will cover 50 adults. Men and women in an age range of 18 to 65 years and a Body Mass Index (BMI) range of 18.5 to 35 kg/m2 should be equally distributed. Subjects have to be patients with chronic kidney failure taking dialysis treatment. 25 patients are taken before and another 25 patients after this treatment. Patients that are taken before dialysis treatment should have been dialysed two and not three days before.

Exclusion Criteria

* amputation of limbs
* gastrointestinal tract illnesses that influence the absorption of substances that are needed for dialysis
* bed-ridden patients patients with clinical relevant hypervolaemia or hypovolaemia
* electrical implant as cardiac pacemaker
* insulin pumps
* pregnancy or breastfeeding period
* subjects who cannot provide an Informed Consent Form (ICF) by themselves
* subjects who might be dependent from the sponsor or the investigation site
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seca GmbH & Co. Kg.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torsten Slowinski, Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité University Medicine Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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BCA-05

Identifier Type: -

Identifier Source: org_study_id