Fluid ShiftsBCM_VolunteerNCT02296294
Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy
A study testing Elo-mel® (Fresenius Kabi Austria) and Body Composition Monitoring in people with Fluid Shifts and Body Fluid Compartments, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device called Body Composition Monitor (BCM) which measures the body composition (i.e. the water content of the body). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fluid Shifts, Body Fluid Compartments
- What is being tested?
- Elo-mel® (Fresenius Kabi Austria) and Body Composition Monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2014to Jul 2016
- Phase
- Interventional
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged between 18 and 50 years
- BMI < 30 kg/m2
- Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study
Who cannot join
- Implanted pacemaker or defibrillator
- Limb amputation identified by physical examination
- Known allergy or hypersensitivity to Elo-Mel
- Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and hypertension with a systolic BP > 160 mmHg) after 5 min resting
- Cardiac insufficiency (NYHA≥ 2)
- Renal insufficiency (GFR ≤ 60 ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device called Body Composition Monitor (BCM) which measures the body composition (i.e. the water content of the body).
Specifically, the investigators will evaluate the use of BCM for correct detection of intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we will test the change over time of the volunteers´ volume status after an intravenous fluid therapy.
Read the detailed description
Technically assisted assessment of volume status may be useful to direct fluid administration.
As a prerequisite the investigators will test a recently developed whole-body bioimpedance spectroscopy device to determine fluid status in volunteers after an intravenous fluid therapy.
The correlation of infused fluid and change of the fluid status measured with Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is still unknown.
Using a three-compartment physiologic tissue model, BCM determine total body fluid volume (TBV), extracellular volume (ECV), intracellular volume (ICV) and fluid overload (FO) as surplus or deficit of 'normal' extracellular volume. The BCM device measures resistance and reactance at 50 discrete frequencies covering the frequency spectrum from 5 to 1000 kHz through the entire patient via 4 electrodes placed on the wrist and ankle.
Fifteen volunteers will be enrolled in a randomized, blinded cross over study. After randomisation into one of two treatments the volunteer will receive either an iv isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour or no fluid therapy. At the second study day the volunteer will obtain the opposite treatment.
We will perform BCM measurements every 10 minutes before, during and after the treatment for 6 hours or until the BCM results return to baseline. The results are stored on a BCM patient card automatically.
The main objective of this study is to detect the administered iv fluid in the extracellular compartment respectively in FO, TBV and ICV.
Secondary outcome parameters include the change over time of ICV, ECV, TBV and FO after the iv therapy at the study day "Fluid Therapy".
- Conditions
- Fluid Shifts, Body Fluid Compartments
- Being tested
- Elo-mel® (Fresenius Kabi Austria), Body Composition Monitoring
- Keywords
- Bioimpedance Spectroscopy, Body Composition Monitor, Fluid Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elo-mel® (Fresenius Kabi Austria)Drug
an iv isotonic crystalloid fluid therapy at a rate of 0,50ml/kg/min for one hour.
Body Composition MonitoringDevice
Also called BCM
BCM measurements every 10 minutes for 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Fluid Therapy | Active comparator | Intravenous isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour.
Body Composition Monitoring every 10 minutes for 6hours. Receives: Drug: Elo-mel® (Fresenius Kabi Austria); Device: Body Composition Monitoring |
| Zero Therapy | Placebo comparator | Body Composition Monitoring every 10 minutes for 6hours. No intravenous fluid therapy Receives: Device: Body Composition Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition, especially Extracellular Volume, Intracellular Volume, Total Body Fluid Volume and Fluid Overload.
The primary outcome parameter is the correct detection of the iv fluid therapy by a corresponding increase in the parameters ExtraCellular Volume (ECV), Total Body Fluid Volume (TBV) and Fluid Overload (FO).
Measured: 6 hours
Secondary outcomes (1)
Change over time of the body fluid compartments after iv fluid therapy
Secondary outcome parameters include the change over time of ICV, ECV, TBV and FO after the iv therapy at the intervention "Fuid Therapy".
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ShiftsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Kabon, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296294
- Sponsor's protocol ID
- BCM Volunteer Study
- Acronym
- BCM_Volunteer
- Status last verified
- Jul 2016
- First submitted
- 18 Nov 2014
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy
- ClinicalTrials.gov ID
- NCT02296294
- Acronym / sponsor ID
- BCM_Volunteer / BCM Volunteer Study
- Conditions
- Fluid Shifts, Body Fluid Compartments
- Keywords
- Bioimpedance Spectroscopy, Body Composition Monitor, Fluid Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Nov 2014 (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.
This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device called Body Composition Monitor (BCM) which measures the body composition (i.e. the water content of the body).
Specifically, the investigators will evaluate the use of BCM for correct detection of intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we will test the change over time of the volunteers´ volume status after an intravenous fluid therapy.
Detailed description
Technically assisted assessment of volume status may be useful to direct fluid administration.
As a prerequisite the investigators will test a recently developed whole-body bioimpedance spectroscopy device to determine fluid status in volunteers after an intravenous fluid therapy.
The correlation of infused fluid and change of the fluid status measured with Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is still unknown.
Using a three-compartment physiologic tissue model, BCM determine total body fluid volume (TBV), extracellular volume (ECV), intracellular volume (ICV) and fluid overload (FO) as surplus or deficit of 'normal' extracellular volume. The BCM device measures resistance and reactance at 50 discrete frequencies covering the frequency spectrum from 5 to 1000 kHz through the entire patient via 4 electrodes placed on the wrist and ankle.
Fifteen volunteers will be enrolled in a randomized, blinded cross over study. After randomisation into one of two treatments the volunteer will receive either an iv isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour or no fluid therapy. At the second study day the volunteer will obtain the opposite treatment.
We will perform BCM measurements every 10 minutes before, during and after the treatment for 6 hours or until the BCM results return to baseline. The results are stored on a BCM patient card automatically.
The main objective of this study is to detect the administered iv fluid in the extracellular compartment respectively in FO, TBV and ICV.
Secondary outcome parameters include the change over time of ICV, ECV, TBV and FO after the iv therapy at the study day "Fluid Therapy".
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid Therapy | Active comparator | Drug: Elo-mel® (Fresenius Kabi Austria), Device: Body Composition MonitoringIntravenous isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour. Body Composition Monitoring every 10 minutes for 6hours. |
| Zero Therapy | Placebo comparator | Device: Body Composition MonitoringBody Composition Monitoring every 10 minutes for 6hours. No intravenous fluid therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers aged between 18 and 50 years
- BMI < 30 kg/m2
- Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study
Key exclusion criteria (6 listed)
- Implanted pacemaker or defibrillator
- Limb amputation identified by physical examination
- Known allergy or hypersensitivity to Elo-Mel
- Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and hypertension with a systolic BP > 160 mmHg) after 5 min resting
- Cardiac insufficiency (NYHA≥ 2)
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 |
|---|---|---|
| Elo-mel® (Fresenius Kabi Austria)an iv isotonic crystalloid fluid therapy at a rate of 0,50ml/kg/min for one hour. | Drug | Fluid Therapy |
| Body Composition MonitoringAlso: BCMBCM measurements every 10 minutes for 6 hours. | Device | Fluid Therapy, Zero Therapy |
Primary outcome
Body composition, especially Extracellular Volume, Intracellular Volume, Total Body Fluid Volume and Fluid Overload.
Time frame: 6 hours
The primary outcome parameter is the correct detection of the iv fluid therapy by a corresponding increase in the parameters ExtraCellular Volume (ECV), Total Body Fluid Volume (TBV) and Fluid Overload (FO).
1 secondary outcome
Change over time of the body fluid compartments after iv fluid therapy
Time frame: 6 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 14 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elo-mel® (Fresenius Kabi Austria) and Body Composition Monitoring in people with Fluid Shifts and Body Fluid Compartments, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 6 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 14 Jul 2016. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
Body composition, especially Extracellular Volume, Intracellular Volume, Total Body Fluid Volume and Fluid Overload. (time frame: 6 hours). 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 14 Jul 2016.