Clinical trial NCT01750671: Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate
Official title: Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutritional Status at the Release of ICU.
Keywords: ICU
Body composition
Nutrition
Survival
Morbidity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
name: Baxter S.A.S
name: University Hospital, Strasbourg, France
name: Hospices Civils de Lyon
First posted: 2012-12-17
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: patients malnourished and non-malnourished

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).

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 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

Primary outcomes:
measure: all-cause mortality
timeFrame: at one year
Secondary outcomes:
measure: Anxiety and depression
timeFrame: at inclusion, M6 and M12
measure: Post-traumatic stress
timeFrame: at inclusion, M6 and M12
measure: Quality of life
timeFrame: at M6 and M12
measure: Degree of activity (Karnofsky questionnaire)
timeFrame: At M6 and M12
measure: Weight
timeFrame: at inclusion, M6 and M12
measure: Body mass index
timeFrame: at inclusion, M6 and M12
measure: Albumin
timeFrame: at inclusion, M6 and M12
measure: Orosomucoid
timeFrame: at inclusion, M6 and M12
measure: Transthyretin (prealbumin)
timeFrame: at inclusion, M6 and M12
measure: Body composition
timeFrame: at inclusion, M6 and M12
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Noël CANO
role: PRINCIPAL_INVESTIGATOR
References: