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

November 28, 2014 updated by: University Hospital, Clermont-Ferrand
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ICU patients
  • Written informed consent
  • Adult patient

Exclusion Criteria:

  • Pregnant patient
  • Cardiac -pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of fat-free mass
Time Frame: From day 4 to day 7
From day 4 to day 7
Evolution of fat-free mass
Time Frame: from day 8 to day 14
from day 8 to day 14
Evolution of fat-free mass
Time Frame: from day 14 to day 28
from day 14 to day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Center of study in Human Nutrition, INRA, Department of Clinical Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 28, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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