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

Nutritional Status at the Release of ICU. Clinical Trial

— FEEDING  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01750671
• Other study ID #: CHU-0127
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2012
• Last updated: December 13, 2012
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 680
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Nutritional Status at the Release of ICU.

Locations

Country	Name	City	State
France	Chu de Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Baxter S.A.S, Hospices Civils de Lyon, Nestlé Healthcare Nutrition, University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality		at one year	Yes
Secondary	Anxiety and depression		at inclusion, M6 and M12	Yes
Secondary	Post-traumatic stress		at inclusion, M6 and M12	Yes
Secondary	Quality of life		at M6 and M12	Yes
Secondary	Degree of activity (Karnofsky questionnaire)		At M6 and M12	Yes
Secondary	Weight		at inclusion, M6 and M12	Yes
Secondary	Body mass index		at inclusion, M6 and M12	Yes
Secondary	Albumin		at inclusion, M6 and M12	Yes
Secondary	Orosomucoid		at inclusion, M6 and M12	Yes
Secondary	Transthyretin (prealbumin)		at inclusion, M6 and M12	Yes
Secondary	Body composition		at inclusion, M6 and M12	Yes