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

• Conditions: Nutritional Status at the Release of ICU.

• Registration Number: NCT01750671
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2012-11-16
• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-13
• Last Update Submitted: 2012-12-13
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17
• Primary Completion: 2015-05
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 680

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality	at one year

Secondary Outcome Measures

Name	Time	Method
Post-traumatic stress	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
Orosomucoid	at inclusion, M6 and M12
Transthyretin (prealbumin)	at inclusion, M6 and M12
Body composition	at inclusion, M6 and M12

Trial Locations

Locations (1)

Chu de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France