Skip to main content
OpenTrials
Completed

NCT Number: NCT00560157

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neurological Diseases Acute Pancreatitis Digestive System Diseases Lung Diseases Major Abdominal Surgery Pancreatic Diseases Pancreatitis Pneumopathy Respiratory Tract Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital A. BECLERE, Clamart, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crucial (enteral tube feeding)

Dietary Supplement

Evaluation of new enteral product, Crucial, in ICU patients

Primary outcomes

  1. Variation of Glutamine after 90 min of enteral product administration

    Time frame: J5

Secondary outcomes

  1. Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress

    Time frame: J1, J5, J8

  2. Tolerance

    Time frame: Daily until J8

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Nov 19, 2007
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.