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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seca GmbH & Co. Kg.
ClinicalTrials.gov Identifier:
NCT01481311
First received: November 10, 2011
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Kidney Diseases
 Device: medical Body Composition Analyzer seca 514/515
Procedure: Deuterium and Sodium Bromide dilution methods

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seca GmbH & Co. Kg.:

Primary Outcome Measures:
  • Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side [ Time Frame: about 2 minutes ] [ Designated as safety issue: No ]
    The measurements are utilized as input for prediction equations to calculate TBW and ECW.


Secondary Outcome Measures:
  • Bioelectrical impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz [ Time Frame: about 2 minutes ] [ Designated as safety issue: No ]
    The measurement is planned to be done for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. In total resistance and reactance at 19 frequencies for 7 body segments are to be measured.

  • TBW [ Time Frame: within 4 hours ] [ Designated as safety issue: No ]
    A D2O dose of 400 mg per kg body weight mixed with tap water is administered orally in the morning fasting and after a 2 hour fluid abstention. The distribution of the stable isotope in the TBW is completed after 4 hours. During this period, the subject remains fasting. Two venous blood samples of 10 ml whole blood are taken immediately before and four hours after taking D2O. The plasma samples are analyzed using Isoptopic Ratio Mass Spectrometry (IRMS).

  • ECW [ Time Frame: within 4 hours ] [ Designated as safety issue: No ]
    Orally administered NaBr is resorbed quickly and completely and almost exclusively distributes in the extracellular compartment. Blood samples of 10 ml are taken immediately before and 4 hours after oral application of 50 mg NaBr per kg body weight. The serum sample is analyzed by X-Ray Fluorescence Spectroscopy (XRF).


Enrollment: 62
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients before dialysis treatment 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.
Patients after dialysis treatment 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Data of 50 patients suffering from kidney disease are planned to be collected.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481311

Locations
Germany
Charité University Medicine Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Seca GmbH & Co. Kg.
Investigators
Principal Investigator: Torsten Slowinski, Dr. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Seca GmbH & Co. Kg.
ClinicalTrials.gov Identifier: NCT01481311     History of Changes
Other Study ID Numbers: BCA-05
Study First Received: November 10, 2011
Last Updated: October 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013