Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods

Phase 4

Completed

• Conditions: Body Composition
• Interventions: Device: body bioelectrical impedance

• Registration Number: NCT01766531
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2012-06
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-28
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ICU patients
• Written informed consent
• Adult patient

Exclusion Criteria

• Pregnant patient
• Cardiac -pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Body bioelectrical impedance	body bioelectrical impedance	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

Primary Outcome Measures

Name	Time	Method
Evolution of fat-free mass	from day 14 to day 28

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France