Skip to main content
OpenTrials
Completed

NCT Number: NCT01481311

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical Body Composition Analyzer seca 514/515

Device

Current of 100 µA

Deuterium and Sodium Bromide dilution methods

Procedure

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

Primary outcomes

  1. Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side

    Time frame: about 2 minutes

    The measurements are utilized as input for prediction equations to calculate TBW and ECW.

Secondary outcomes

  1. 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

    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.

  2. TBW

    Time frame: within 4 hours

    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).

  3. ECW

    Time frame: within 4 hours

    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).

Sponsors and collaborators

Lead sponsor

Seca GmbH & Co. Kg.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 29, 2011
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.