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

NCT ID: NCT01750671

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

680 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Nutritional Status at the Release of ICU.

Keywords

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ICU Body composition Nutrition Survival Morbidity

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

Baxter S.A.S

UNKNOWN

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noël CANO

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

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Chu de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

Phone: 04 73 75 11 95

Email: [email protected]

Facility Contacts

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Patrick LACARIN

Role: primary

Other Identifiers

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CHU-0127

Identifier Type: -

Identifier Source: org_study_id