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

Nestlé

Status and phase: Completed; Phase 4

Conditions: Neurological Diseases; Major Abdominal Surgery; Acute Pancreatitis; Pneumopathy

Treatments: Dietary Supplement: Crucial (enteral tube feeding)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560157

NCNF 0401

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

I

Active Comparator group

Description:

Sondalis HP

Treatment:

Dietary Supplement: Crucial (enteral tube feeding)

II

Experimental group

Description:

Crucial

Treatment:

Dietary Supplement: Crucial (enteral tube feeding)