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Immunonutrition vs Standard Nutrition in Upper GI Surgery
NCT00732849Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2002
- Primary completion
- Sep 2002
- Countries
- 1
- Sponsor
- Jagiellonian University
- Modality
- Lipid-based Nanoparticles, Recombinant Proteins and Enzymes, Peptides
- Conditions
- post-operative infection
01
Overview
Phase 4, randomised, open-label trial of eicosapentaenoic acid + docosahexaenoic acid and alanyl glutamine in post-operative infection (4 arms), sponsored by Jagiellonian University. Primary endpoint: Incidence of infectious complications. Started Jun 2002; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Standard Enteral
Standard Enteral Nutrition (Peptisorb)
Standard Parenteral
Standard Parenteral Nutrition
Immuno Enteral
Immunomodulating Enteral Nutrition (Reconvan)
Immuno Parenteral
Immunomodulating Parenteral Nutrition (Omegaven + Dipeptiven)
03
Who it enrols
Adult patients (18-80 years) with malnutrition (defined by NRI) scheduled for elective total/distal subtotal gastrectomy or pancreaticoduodenectomy, with Karnofsky score >= 80 and adequate organ function. Excludes patients with disseminated tumors, ASA class 4-5, or renal/liver failure.
04
Endpoints
Primary
Incidence of infectious complications
Secondary
Overall morbidity rate
Overall mortality rate
Length of hospital stay
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