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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 18, 2013
Last verified: November 2013
  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:


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, functionality 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
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 18, 2013
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:
Nervous System Diseases
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014