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

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ClinicalTrials.gov Identifier: NCT01750671
Recruitment Status : Unknown
Verified December 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
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

Brief Summary:

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 or disease
Nutritional Status at the Release of ICU.

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
Estimated Enrollment : 680 participants
Observational Model: Cohort
Official Title: Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate
Study Start Date : December 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015



Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: at one year ]

Secondary Outcome Measures :
  1. Anxiety and depression [ Time Frame: at inclusion, M6 and M12 ]
  2. Post-traumatic stress [ Time Frame: at inclusion, M6 and M12 ]
  3. Quality of life [ Time Frame: at M6 and M12 ]
  4. Degree of activity (Karnofsky questionnaire) [ Time Frame: At M6 and M12 ]
  5. Weight [ Time Frame: at inclusion, M6 and M12 ]
  6. Body mass index [ Time Frame: at inclusion, M6 and M12 ]
  7. Albumin [ Time Frame: at inclusion, M6 and M12 ]
  8. Orosomucoid [ Time Frame: at inclusion, M6 and M12 ]
  9. Transthyretin (prealbumin) [ Time Frame: at inclusion, M6 and M12 ]
  10. Body composition [ Time Frame: at inclusion, M6 and M12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01750671     History of Changes
Other Study ID Numbers: CHU-0127
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

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