- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481311
Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Berlin, Germany, 10117
- Charite University Medicine Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients before dialysis treatment
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Current of 100 µA
Orally administered to the subject in a solution with 100 ml tap water.
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Patients after dialysis treatment
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Current of 100 µA
Orally administered to the subject in a solution with 100 ml tap water.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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about 2 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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about 2 minutes
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TBW
Time Frame: within 4 hours
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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).
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within 4 hours
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ECW
Time Frame: within 4 hours
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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).
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within 4 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Torsten Slowinski, Dr., Charite University, Berlin, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCA-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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