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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00560157
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : November 19, 2013
Sponsor:
Information provided by:

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Study Start Date : December 2002
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00560157     History of Changes
Other Study ID Numbers: NCNF 0401
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Nestlé:
ICU patients

Additional relevant MeSH terms:
Pancreatitis
Nervous System Diseases
Pancreatic Diseases
Digestive System Diseases