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

Primary Purpose

Neurological Diseases, Pneumopathy, Major Abdominal Surgery

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Crucial (enteral tube feeding)
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurological Diseases focused on measuring ICU patients

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital A. BECLERE
  • Hopital Saint Antoine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

I

II

Arm Description

Sondalis HP

Crucial

Outcomes

Primary Outcome Measures

Variation of Glutamine after 90 min of enteral product administration

Secondary Outcome Measures

Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress
Tolerance

Full Information

First Posted
November 6, 2007
Last Updated
November 18, 2013
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT00560157
Brief Title
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Official Title
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Diseases, Pneumopathy, Major Abdominal Surgery, Acute Pancreatitis
Keywords
ICU patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Sondalis HP
Arm Title
II
Arm Type
Experimental
Arm Description
Crucial
Intervention Type
Dietary Supplement
Intervention Name(s)
Crucial (enteral tube feeding)
Intervention Description
Evaluation of new enteral product, Crucial, in ICU patients
Primary Outcome Measure Information:
Title
Variation of Glutamine after 90 min of enteral product administration
Time Frame
J5
Secondary Outcome Measure Information:
Title
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress
Time Frame
J1, J5, J8
Title
Tolerance
Time Frame
Daily until J8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc CYNOBER, PhD
Organizational Affiliation
University PARIS V
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital A. BECLERE
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France

12. IPD Sharing Statement

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

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