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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
Nestlé Healthcare Nutrition
Baxter S.A.S
University Hospital, Strasbourg, France
Hospices Civils de Lyon
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01750671
First received: November 16, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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).


Condition
Nutritional Status at the Release of ICU.

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • all-cause mortality [ Time Frame: at one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anxiety and depression [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]
  • Post-traumatic stress [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: at M6 and M12 ] [ Designated as safety issue: Yes ]
  • Degree of activity (Karnofsky questionnaire) [ Time Frame: At M6 and M12 ] [ Designated as safety issue: Yes ]
  • Weight [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]
  • Body mass index [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]
  • Albumin [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]
  • Orosomucoid [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]
  • Transthyretin (prealbumin) [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]
  • Body composition [ Time Frame: at inclusion, M6 and M12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 680
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients malnourished and non-malnourished

Criteria

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
  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: NCT01750671

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
Chu de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Noël CANO         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Nestlé Healthcare Nutrition
Baxter S.A.S
University Hospital, Strasbourg, France
Hospices Civils de Lyon
Investigators
Principal Investigator: Noël CANO CHU de Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01750671     History of Changes
Other Study ID Numbers: CHU-0127
Study First Received: November 16, 2012
Last Updated: December 13, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
ICU
Body composition
Nutrition
Survival
Morbidity

ClinicalTrials.gov processed this record on July 24, 2014