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

Body Composition Clinical Trial

— IMPREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766531
• Other study ID #: CHU-0135
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2013
• Last updated: November 28, 2014
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ICU patients

• Written informed consent

• Adult patient

Exclusion Criteria:

• Pregnant patient

• Cardiac -pacemaker

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Composition

Intervention

Device:
• body bioelectrical impedance

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Center of study in Human Nutrition, INRA, Department of Clinical Nutrition

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of fat-free mass		From day 4 to day 7	Yes
Primary	Evolution of fat-free mass		from day 8 to day 14	Yes
Primary	Evolution of fat-free mass		from day 14 to day 28	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes