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

This study has been completed.
Sponsor:
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT00560157
First received: November 6, 2007
Last updated: November 16, 2007
Last verified: November 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Neurological Diseases
Pneumopathy
Major Abdominal Surgery
Acute Pancreatitis
 Dietary Supplement: Crucial (enteral tube feeding)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Variation of Glutamine after 90 min of enteral product administration [ Time Frame: J5 ]

Secondary Outcome Measures:
  • Nutritional parameters, immunologic parameters, functionnality renal, Biological marker of oxidative stress [ Time Frame: J1, J5, J8 ]
  • Tolerance [ Time Frame: Daily until J8 ]

Enrollment: 22
Study Start Date: December 2002
Study Completion Date: March 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 beguining at the latest in the three days following the agression
  • ICU patients hospitalised for:
  • neurologic affections
  • pneumopathy
  • major abdominal surgery or serious acute pancreatitis
  • written informed consent

Exclusion Criteria:

  • pregnancy or breast feeding
  • immunosuppressive therapy
  • radiotherapy or chemiotherapy 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 growwing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560157

Locations
France
Hopital A. BECLERE
Clamart, France, 92141
Hopital Saint Antoine
Paris, France, 75571
Sponsors and Collaborators
Nestlé
Investigators
Study Chair: Luc CYNOBER, PhD University PARIS V
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00560157     History of Changes
Other Study ID Numbers: NCNF 0401
Study First Received: November 6, 2007
Last Updated: November 16, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nestlé:
ICU patients

Additional relevant MeSH terms:
Lung Diseases
Nervous System Diseases
Pancreatitis
 Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013