NCT01766531CompletedPhase 4
Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods
University Hospital, Clermont-Ferrand2 sites in 1 country200 target enrollmentStarted: June 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Evolution of fat-free mass
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ICU patients
- •Written informed consent
- •Adult patient
Exclusion Criteria
- •Pregnant patient
- •Cardiac -pacemaker
Outcomes
Primary Outcomes
Evolution of fat-free mass
Time Frame: from day 14 to day 28
Secondary Outcomes
- Performance of the impedance to measure body evolution(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(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(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(in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28)
Investigators
Study Sites (2)
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