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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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ClinicalTrials.gov Identifier: NCT01766531
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : December 2, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Body Composition Device: body bioelectrical impedance Phase 4

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  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2012
Primary Completion Date : November 2012
Study Completion Date : November 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Evolution of fat-free mass [ Time Frame: From day 4 to day 7 ]
  2. Evolution of fat-free mass [ Time Frame: from day 8 to day 14 ]
  3. Evolution of fat-free mass [ Time Frame: from day 14 to day 28 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU patients
  • Written informed consent
  • Adult patient

Exclusion Criteria:

  • Pregnant patient
  • Cardiac -pacemaker
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766531


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01766531     History of Changes
Other Study ID Numbers: CHU-0135
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

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