Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
1 other identifier
interventional
22
1 country
2
Brief Summary
Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2002
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 6, 2007
CompletedFirst Posted
Study publicly available on registry
November 19, 2007
CompletedNovember 19, 2013
November 1, 2013
3.2 years
November 6, 2007
November 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variation of Glutamine after 90 min of enteral product administration
J5
Secondary Outcomes (2)
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress
J1, J5, J8
Tolerance
Daily until J8
Study Arms (2)
I
ACTIVE COMPARATORSondalis HP
II
EXPERIMENTALCrucial
Interventions
Evaluation of new enteral product, Crucial, in ICU patients
Eligibility Criteria
You may qualify if:
- \<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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hopital A. BECLERE
Clamart, 92141, France
Hopital Saint Antoine
Paris, 75571, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luc CYNOBER, PhD
University PARIS V
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 6, 2007
First Posted
November 19, 2007
Study Start
December 1, 2002
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
November 19, 2013
Record last verified: 2013-11