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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01766531 |
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Date of registration:
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10/01/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods
IMPREA |
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Scientific title:
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Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01766531 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Sébastien PERBET |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ICU patients
- Written informed consent
- Adult patient
Exclusion Criteria:
- Pregnant patient
- Cardiac -pacemaker
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Body Composition
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Intervention(s)
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Device: body bioelectrical impedance
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Primary Outcome(s)
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Evolution of fat-free mass
[Time Frame: From day 4 to day 7]
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Evolution of fat-free mass
[Time Frame: from day 8 to day 14]
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Evolution of fat-free mass
[Time Frame: from day 14 to day 28]
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Secondary Outcome(s)
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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]
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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