Clinical trial NCT00425529: Tolerance and Practicality of Module AOX
Official title: Tolerance and Practicality of Module AOX - a Modular Device for Supplementation of Enteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastrointestinal Diseases
Nutrition
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2007-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Tolerance: stool outcome (frequency, consistency), diarrhea, faltulence, abdominal pain, amount of feeding according to goal, changes of amount fed, discontinuation of feeding
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Paul AM van Leeuwen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: