Kidney DiseasesNCT01481311
Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
An observational study of Kidney Diseases, run by Seca GmbH & Co. Kg. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- medical Body Composition Analyzer seca 514/515 and Deuterium and Sodium Bromide dilution methods
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data of 50 patients suffering from kidney disease are planned to be collected.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité University Medicine Berlin
Berlin, State of Berlin, 10117
About this study
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.
- Conditions
- Kidney Diseases
- Being tested
- medical Body Composition Analyzer seca 514/515, Deuterium and Sodium Bromide dilution methods
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical Body Composition Analyzer seca 514/515Device
Current of 100 µA
Deuterium and Sodium Bromide dilution methodsProcedure or surgery
Orally administered to the subject in a solution with 100 ml tap water.
| Study group | Role | What they receive |
|---|---|---|
| Patients before dialysis treatment | Not described Receives: Device: medical Body Composition Analyzer seca 514/515; Procedure: Deuterium and Sodium Bromide dilution methods | |
| Patients after dialysis treatment | Not described Receives: Device: medical Body Composition Analyzer seca 514/515; Procedure: Deuterium and Sodium Bromide dilution methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 2 minutes
Secondary outcomes (3)
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.
Measured: about 2 minutes
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).
Measured: within 4 hours
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).
Measured: within 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seca GmbH & Co. Kg.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torsten Slowinski, Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481311
- Sponsor's protocol ID
- BCA-05
- Status last verified
- Oct 2012
- First submitted
- 10 Nov 2011
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
- ClinicalTrials.gov ID
- NCT01481311
- Acronym / sponsor ID
- BCA-05
- Conditions
- Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Seca GmbH & Co. Kg.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients before dialysis treatment | – | Device: medical Body Composition Analyzer seca 514/515, Procedure: Deuterium and Sodium Bromide dilution methods |
| Patients after dialysis treatment | – | Device: medical Body Composition Analyzer seca 514/515, Procedure: Deuterium and Sodium Bromide dilution methods |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data of 50 patients suffering from kidney disease are planned to be collected.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical Body Composition Analyzer seca 514/515Current of 100 µA | Device | Patients after dialysis treatment, Patients before dialysis treatment |
| Deuterium and Sodium Bromide dilution methodsOrally administered to the subject in a solution with 100 ml tap water. | Procedure or surgery | Patients after dialysis treatment, Patients before dialysis treatment |
Primary outcome
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.
3 secondary outcomes
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
TBW
Time frame: within 4 hours
ECW
Time frame: within 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten Slowinski, Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by Seca GmbH & Co. Kg. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side (time frame: about 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.