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Clinical Trials/NCT01750671
NCT01750671
Unknown
Not Applicable

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

University Hospital, Clermont-Ferrand1 site in 1 country680 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutritional Status at the Release of ICU.
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
680
Locations
1
Primary Endpoint
all-cause mortality
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
December 2015
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

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:
  • Ventilatory support (invasive or noninvasive)
  • Administration of catecholamines
  • 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

Outcomes

Primary Outcomes

all-cause mortality

Time Frame: at one year

Secondary Outcomes

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

Study Sites (1)

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