NCT01766531

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

January 10, 2013

Last Update Submit

November 28, 2014

Conditions

Body Composition

Keywords

Bioelectrical impedanceNutritionPhase angleICU patients

Outcome Measures

Primary Outcomes (3)

  • Evolution of fat-free mass

    From day 4 to day 7

  • Evolution of fat-free mass

    from day 8 to day 14

  • Evolution of fat-free mass

    from day 14 to day 28

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Body bioelectrical impedance

EXPERIMENTAL

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

Interventions

body bioelectrical impedanceDEVICE
Body bioelectrical impedance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patients
  • Written informed consent
  • Adult patient

You may not qualify if:

  • Pregnant patient
  • Cardiac -pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 11, 2013

Study Start

June 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

FR(1)