Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate (FEEDING)

December 13, 2012 updated by: University Hospital, Clermont-Ferrand

It is established that the surviving patients after a stay in the ICU are characterized by frequent malnutrition and morbidity and mortality. The main goal of this work is to study the relationship between nutritional statuses during ICU hospitalization, whatever its determinants, and quality of life, morbidity and mortality at one year.

The hypothesis of the study is that the presence of under nutrition is responsible for a 10% increase in crude mortality at one year (which would be respectively 30% for malnourished patients and 20% for non-malnourished patients).

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a multicenter cohort study of a 30-month follow-up on patients after a stay in ICU.

Nutritional parameters and evaluation of the quality of life will be collected during hospitalization and output during a visit to the Clinical Research Associate at 6 months and one year. Survival will be also noted. These parameters will be studied in comparative patients malnourished and non-malnourished.

Study Type

Observational

Enrollment (Anticipated)

680

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 de 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

Sampling Method

Probability Sample

Study Population

patients malnourished and non-malnourished

Description

Inclusion Criteria:

  • Patients of both sexes, age greater than or equal to 18 years

    • Hospitalized more than 72 hours in the ICU

    • Requiring at least one support organ failure:

      1. Ventilatory support (invasive or noninvasive)
      2. Administration of catecholamines
      3. Extrarenal purification whatever technique
    • Affiliated to a social security system
    • Having given free, informed written consent

Exclusion Criteria:

  • Patients with end-stage disease or for which a limitation of care was decided

    • Pregnant women
    • Patients with minor or under guardianship
    • Incapacitated adults and psychiatric inpatients

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

  • Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: at one year
at one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety and depression
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12
Post-traumatic stress
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12
Quality of life
Time Frame: at M6 and M12
at M6 and M12
Degree of activity (Karnofsky questionnaire)
Time Frame: At M6 and M12
At M6 and M12
Weight
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12
Body mass index
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12
Albumin
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12
Orosomucoid
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12
Transthyretin (prealbumin)
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12
Body composition
Time Frame: at inclusion, M6 and M12
at inclusion, M6 and M12

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Hospices Civils de Lyon
University Hospital, Strasbourg, France
Nestlé
Baxter S.A.S

Investigators

  • Principal Investigator: Noël CANO, CHU de Clermont-Ferrand

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

December 1, 2012

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Nutritional Status at the Release of ICU.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe