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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560157
• Other study ID #: NCNF 0401
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2007
• Last updated: November 18, 2013
• Start date: December 2002
• Est. completion date: March 2006

Study information

• Verified date: November 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Major Abdominal Surgery
• Nervous System Diseases
• Neurological Diseases
• Pancreatitis
• Pneumopathy

Intervention

Dietary Supplement:
• Crucial (enteral tube feeding)
Evaluation of new enteral product, Crucial, in ICU patients

Locations

Country	Name	City	State
France	Hopital A. BECLERE	Clamart
France	Hopital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of Glutamine after 90 min of enteral product administration		J5
Secondary	Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress		J1, J5, J8
Secondary	Tolerance		Daily until J8