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

Phase 4

Completed

• Conditions: Pneumopathy; Major Abdominal Surgery; Acute Pancreatitis; Neurological Diseases
• Interventions: Dietary Supplement: Crucial (enteral tube feeding)

• Registration Number: NCT00560157
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II	Crucial (enteral tube feeding)	Crucial
I	Crucial (enteral tube feeding)	Sondalis HP

Primary Outcome Measures

Name	Time	Method
Variation of Glutamine after 90 min of enteral product administration	J5

Secondary Outcome Measures

Name	Time	Method
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress	J1, J5, J8
Tolerance	Daily until J8

Trial Locations

Locations (2)

Hopital A. BECLERE; 🇫🇷 Clamart, France

Hopital Saint Antoine; 🇫🇷 Paris, France