Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.
Unknown status
National Taiwan University Hospital
Phase 4
2005-03-01
1. A prospective, controlled, randomized, study evaluating the clinical efficacy, including
nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented
parenteral nutrition in subjects of SICU.
2. Study patients are the critical ill patients in SICU of NTUH and the enrolled patients
will be 30 subjects ,including 15 in each treatment group.
3. During parenteral nutrition, fat emulsions will be given separately from amino acid and
glucose solutions. Infusion pump must be used.The recommended infusion duration of the
daily lipid emulsion is 16 hours (0.0625 g fat/kg B.W./hour) from 8:00 am to 12:00 pm.
4. During the study the assessments of safety and efficacy are to be performed according to
case report form. The assessment for safety variables including blood pressure、heat rate
、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In
addition，the assessments for efficacy variables including
lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40
ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital
stay、mortality etc.
Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)
Completed
Humanis Klinikum Niederosterreich
Phase 3
2004-09-01
The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to
the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with
active rheumatoid arthritis.
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