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

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481311
• Other study ID #: BCA-05
• Status: Completed
• Phase: N/A
• First received: November 10, 2011
• Last updated: October 2, 2012
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Seca GmbH & Co. Kg.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Charité University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Seca GmbH & Co. Kg.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side	The measurements are utilized as input for prediction equations to calculate TBW and ECW.	about 2 minutes	No
Secondary	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	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.	about 2 minutes	No
Secondary	TBW	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).	within 4 hours	No
Secondary	ECW	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).	within 4 hours	No