Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients

NCT ID: NCT00560157

Last Updated: 2013-11-19

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2006-03-31

Brief Summary

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Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients

Detailed Description

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Conditions

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Neurological Diseases Pneumopathy Major Abdominal Surgery Acute Pancreatitis

Keywords

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ICU patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Sondalis HP

Group Type ACTIVE_COMPARATOR

Crucial (enteral tube feeding)

Intervention Type DIETARY_SUPPLEMENT

Evaluation of new enteral product, Crucial, in ICU patients

II

Crucial

Group Type EXPERIMENTAL

Crucial (enteral tube feeding)

Intervention Type DIETARY_SUPPLEMENT

Evaluation of new enteral product, Crucial, in ICU patients

Interventions

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Crucial (enteral tube feeding)

Evaluation of new enteral product, Crucial, in ICU patients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 18\<age\<89, ASA score\<4 , SAPS II score\>10
* requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression
* ICU patients hospitalized for:
* neurologic affections
* pneumopathy
* major abdominal surgery or serious acute pancreatitis
* written informed consent

Exclusion Criteria

* pregnancy or breast feeding
* immunosuppressive therapy
* radiotherapy or chemotherapy in the last six month
* uncontrolled septic choc
* auto-immune disease
* hepatic,renal or digestive insufficiency
* hyperlipidemia
* diabetes mellitus type 1
* digestive malabsorption
* life threatening situation
* treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Principal Investigators

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Luc CYNOBER, PhD

Role: STUDY_CHAIR

University PARIS V

Locations

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Hopital A. BECLERE

Clamart, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Countries

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France

Other Identifiers

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NCNF 0401

Identifier Type: -

Identifier Source: org_study_id