Tolerance and Practicality of Module AOX
Primary Purpose
Gastrointestinal Diseases, Nutrition
Status
Completed
Phase
Early Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Module AOX (attached to Sondalis ISO)
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Diseases
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
Sites / Locations
- VU Medical Center
Outcomes
Primary Outcome Measures
Tolerance: stool outcome (frequency, consistency), diarrhea, faltulence, abdominal pain, amount of feeding according to goal, changes of amount fed, discontinuation of feeding
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
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
Full Information
NCT ID
NCT00425529
First Posted
January 22, 2007
Last Updated
January 22, 2007
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT00425529
Brief Title
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
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases, Nutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Module AOX (attached to Sondalis ISO)
Primary Outcome Measure Information:
Title
Tolerance: stool outcome (frequency, consistency), diarrhea, faltulence, abdominal pain, amount of feeding according to goal, changes of amount fed, discontinuation of feeding
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul AM van Leeuwen, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1007 MB
Country
Netherlands
12. IPD Sharing Statement
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Tolerance and Practicality of Module AOX
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