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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
Center of study in Human Nutrition, INRA, Department of Clinical Nutrition
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01766531
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Body Composition
Device: body bioelectrical impedance
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Evolution of fat-free mass [ Time Frame: From day 4 to day 7 ] [ Designated as safety issue: Yes ]
  • Evolution of fat-free mass [ Time Frame: from day 8 to day 14 ] [ Designated as safety issue: Yes ]
  • Evolution of fat-free mass [ Time Frame: from day 14 to day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Device: body bioelectrical impedance

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU patients
  • Written informed consent
  • Adult patient

Exclusion Criteria:

  • Pregnant patient
  • Cardiac -pacemaker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766531

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Center of study in Human Nutrition, INRA, Department of Clinical Nutrition
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01766531     History of Changes
Other Study ID Numbers: CHU-0135
Study First Received: January 10, 2013
Last Updated: January 10, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Bioelectrical impedance
Nutrition
Phase angle
ICU patients

ClinicalTrials.gov processed this record on April 17, 2014