Status:
COMPLETED
Tolerance and Practicality of Module AOX
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Gastrointestinal Diseases
Nutrition
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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 st...
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, requirement...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00425529
Start Date
February 1 2002
End Date
May 1 2003
Last Update
January 23 2007
Active Locations (1)
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1
VU Medical Center
Amsterdam, North Holland, Netherlands, 1007 MB