Tolerance and Practicality of Module AOX

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425529
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : January 23, 2007
Information provided by:
VU University Medical Center

Brief Summary:

The primary objective of this clinical trial is to test the tolerance and practicality of the new device Module AOX.

The secondary objective is to determine the changes in oxidative, antioxidative status, plasma free amino acids, and various immune parameters in critically ill patients receiving the enteral nutrition with and without using Module AOX.

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Nutrition Device: Module AOX (attached to Sondalis ISO) Early Phase 1

Detailed Description:

Surgery and trauma induce hypercatabolism accompanied by a systemic immunoinflammtory response and massive production of reactive oxygen species at the site of injury. In these situations, requirements for certain amino acids (glutamine, cysteine) and antioxidant micronutrients (zinc, vitamin E, vitamin C, beta-caroteen, selenium) are markedly increased and may not be covered by the levels normally present in standard enteral diets, especially in the early phase when enteral nutrition is introduced gradually. Thus, supplementation with amino acids and antioxidant micronutrients may be appropiate in order to optimize nutritional support in such patients.

The administration of selected nutrients via modular devices added to a standard enteral formulation is an attractive means of providing optimized nutrition support for specific disease states. Module AOX is intended for supplementation of patients requiring nutritional support for a condition in which oxidative stress is expected. The module contains:

  • Glutamine: to support gut mucosal and immune function, to minimize early depletion of glutamine stores and preserve body protein
  • Cysteine: to support synthesis of glutathione, an important cellular antioxidant, and to support the synthesis of acute phase proteins
  • Vitamin E, vitamin C and beta-caroteen: water- and lipid-soluble antioxidant micronutrients to boost antioxidant defenses
  • Zinc: to compensate for increased losses and to support protein synthesis, immune function and wound healing
  • Selenium: to compensate for increased losses, support antioxidant defenses and immune function

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tolerance and Practicality of Module AOX - a Modular Device for Supplementation of Enteral Nutrition
Study Start Date : February 2002
Study Completion Date : May 2003

Primary Outcome Measures :
  1. Tolerance: stool outcome (frequency, consistency), diarrhea, faltulence, abdominal pain, amount of feeding according to goal, changes of amount fed, discontinuation of feeding
  2. Practicality: time for connecting the device to the pouch, time needing for mixing content of device with the content of the enteral feding pouch, clotting of theadministration set, product flow,leakage, clarity of instructions of usage

Secondary Outcome Measures :
  1. vitamin C, Vitamin E. beta-caroteen, GSH/GSSG, cysteine/cystine, GPx, isoprostane, TAS, Zn, Se, plasma free amino acids, HLADR, TNF soluble receptors (55/75), LBP, BPI, IL-1 IR II, leptin, soluble leptin receptor, IL-6, IL-8, and microciological safety

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients who will undergo major surgery of esophagus, stomach or pancreas
  • patients who will be eligible for jejunostomy feeding
  • age >18 and <75 y
  • BMI < 35
  • having obtained his/her or his/her legal representative's informed consent

Exclusion Criteria:

  • patients with a history of main cardiovascular or kidney disease
  • weigth loss >10% during the last 6 months
  • patients who have received corticosteroids, or investigational drugs, in the last 6 weekd prior to surgery
  • patients with HIV infection
  • patients who are participating in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00425529

VU Medical Center
Amsterdam, Noord-Holland, Netherlands, 1007 MB
Sponsors and Collaborators
VU University Medical Center
Principal Investigator: Paul AM van Leeuwen, MD, PhD VU University Medical Center Identifier: NCT00425529     History of Changes
Other Study ID Numbers: 01.04.CLI
First Posted: January 23, 2007    Key Record Dates
Last Update Posted: January 23, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases