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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)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014