Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate (FEEDING)
|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
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.|
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|
|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|
- all-cause mortality [ Time Frame: at one year ]
- Anxiety and depression [ Time Frame: at inclusion, M6 and M12 ]
- Post-traumatic stress [ Time Frame: at inclusion, M6 and M12 ]
- Quality of life [ Time Frame: at M6 and M12 ]
- Degree of activity (Karnofsky questionnaire) [ Time Frame: At M6 and M12 ]
- Weight [ Time Frame: at inclusion, M6 and M12 ]
- Body mass index [ Time Frame: at inclusion, M6 and M12 ]
- Albumin [ Time Frame: at inclusion, M6 and M12 ]
- Orosomucoid [ Time Frame: at inclusion, M6 and M12 ]
- Transthyretin (prealbumin) [ Time Frame: at inclusion, M6 and M12 ]
- Body composition [ Time Frame: at inclusion, M6 and M12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750671
|Contact: Patrick LACARIN||04 73 75 11 firstname.lastname@example.org|
|Chu de Clermont-Ferrand||Not yet recruiting|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 email@example.com|
|Principal Investigator: Noël CANO|
|Principal Investigator:||Noël CANO||CHU de Clermont-Ferrand|