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

November 18, 2013 updated by: Société des Produits Nestlé (SPN)
Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92141
        • Hopital A. BECLERE
      • Paris, France, 75571
        • Hopital Saint Antoine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I
Sondalis HP
Dietary supplement: Crucial (enteral tube feeding)
Evaluation of new enteral product, Crucial, in ICU patients
Experimental: II
Crucial
Dietary supplement: Crucial (enteral tube feeding)
Evaluation of new enteral product, Crucial, in ICU patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of Glutamine after 90 min of enteral product administration
Time Frame: J5
J5

Secondary Outcome Measures

Outcome Measure
Time Frame
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress
Time Frame: J1, J5, J8
J1, J5, J8
Tolerance
Time Frame: Daily until J8
Daily until J8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Study Chair: Luc CYNOBER, PhD, University PARIS V

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

November 6, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCNF 0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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