Body CompositionPhase 4IMPREANCT01766531
Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods
A Phase 4 study testing body bioelectrical impedance in people with Body Composition, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Composition
- What is being tested?
- body bioelectrical impedance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Nov 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients
- Written informed consent
- Adult patient
Who cannot join
- Pregnant patient
- Cardiac -pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.
Read the detailed description
Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water); comparison with four methods for assessing nutritional status. ; compare length of mechanical ventilation, length in ICU and energy expenditure rest between malnourished and non-malnourished patient.
- Conditions
- Body Composition
- Being tested
- body bioelectrical impedance
- Keywords
- Bioelectrical impedance, Nutrition, Phase angle, ICU patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body bioelectrical impedanceDevice
| Study group | Role | What they receive |
|---|---|---|
| Body bioelectrical impedance | Experimental | comparison with four methods for assessing nutritional status. ; compare length of mechanical ventilation, length in ICU and energy expenditure rest between malnourished and non-malnourished patient Receives: Device: body bioelectrical impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of fat-free mass
Measured: From day 4 to day 7
Evolution of fat-free mass
Measured: from day 8 to day 14
Evolution of fat-free mass
Measured: from day 14 to day 28
Secondary outcomes (4)
Performance of the impedance to measure body evolution
Measured: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Evolution of phase angle using bioelectrical impedance analysis
Measured: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Comparison with four methods for assessing nutritional status
Measured: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Compare length of mecanical ventilation, length in ICU and energy expenditure rest between malnourished ans non-malnourished patient
Measured: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Center of study in Human Nutrition, INRA, Department of Clinical Nutrition
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766531
- Sponsor's protocol ID
- CHU-0135
- Acronym
- IMPREA
- Status last verified
- Nov 2014
- First submitted
- 10 Jan 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods
- ClinicalTrials.gov ID
- NCT01766531
- Acronym / sponsor ID
- IMPREA / CHU-0135
- Conditions
- Body Composition
- Keywords
- Bioelectrical impedance, Nutrition, Phase angle, ICU patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Center of study in Human Nutrition, INRA, Department of Clinical Nutrition
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Jan 2013 (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.
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.
Detailed description
Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water); comparison with four methods for assessing nutritional status. ; compare length of mechanical ventilation, length in ICU and energy expenditure rest between malnourished and non-malnourished patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body bioelectrical impedance | Experimental | Device: body bioelectrical impedancecomparison with four methods for assessing nutritional status. ; compare length of mechanical ventilation, length in ICU and energy expenditure rest between malnourished and non-malnourished patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICU patients
- Written informed consent
- Adult patient
Key exclusion criteria (2 listed)
- Pregnant patient
- Cardiac -pacemaker
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 |
|---|---|---|
| body bioelectrical impedance | Device | Body bioelectrical impedance |
Primary outcome
Evolution of fat-free mass
Time frame: From day 4 to day 7
Evolution of fat-free mass
Time frame: from day 8 to day 14
Evolution of fat-free mass
Time frame: from day 14 to day 28
4 secondary outcomes
Performance of the impedance to measure body evolution
Time frame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Evolution of phase angle using bioelectrical impedance analysis
Time frame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Comparison with four methods for assessing nutritional status
Time frame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Compare length of mecanical ventilation, length in ICU and energy expenditure rest between malnourished ans non-malnourished patient
Time frame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
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 2 Dec 2014.
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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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing body bioelectrical impedance in people with Body Composition, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 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 2 Dec 2014. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evolution of fat-free mass (time frame: From day 4 to day 7). The study lists 3 primary outcomes in all. 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 2 Dec 2014.