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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00560157
Enrollment
22
Registered
2007-11-19
Start date
2002-12-31
Completion date
2006-03-31
Last updated
2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis, Major Abdominal Surgery, Neurological Diseases, Pneumopathy

Keywords

ICU patients

Brief summary

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

Interventions

DIETARY_SUPPLEMENTCrucial (enteral tube feeding)

Evaluation of new enteral product, Crucial, in ICU patients

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Variation of Glutamine after 90 min of enteral product administrationJ5

Secondary

MeasureTime frame
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stressJ1, J5, J8
ToleranceDaily until J8

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026