Official Title
Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Phase
Phase 4Lead Sponsor
Li Shin HospitalStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Severe SepsisIntervention/Treatment
icosapent ethyl ...Study Participants
100The purpose of this study is to determine whether a fish oil-based lipid emulsion, enriched with ω-3 fatty acids, reduce proinflammatory cytokines and mortality rate in critically ill patients with severe sepsis.
The enrolled patients will be randomized to receive either supplementation of fish oil-based lipid emulsion (10 % Omegaven) as group 1 or placebo (0.9% Normal Saline) as group 2 via a central venous catheter within 24 hours after ICU admission, 100 ml daily for 5 days, respectively.
The enrolled patients will be randomized to receive either supplementation of fish oil-based lipid emulsion (10 % Omegaven) as group 1 or placebo (0.9% Normal Saline) as group 2 via a central venous catheter within 24 hours after ICU admission, 100 ml daily for 5 days, respectively.
Inclusion Criteria: Patients admitted to Li Shin Hospital's ICU with a main diagnosis of severe sepsis. Exclusion Criteria: Age of ﹤15 years Pregnancy Patients treated with immunosuppressive drugs or the equivalent of hydrocortisone more than 300 mg daily Plasma triglyceride concentration of more than 400 mg/dl Infection with human immunodeficiency virus Anticipated rapid fatality from irreversible underlying disease or malignancy Severe hemorrhagic disorders Acute myocardial infarction Recent stroke (within 3 month) Suspected or proven pulmonary embolism Cirrhotic liver and/or acute hepatitis ( elevation of serum GOT or GPT > 5 times of normal upper limit) Chronic renal failure (Cr >3.5 mg/dl upon admission) or end stage of renal diseases Allergic reactions against fish or egg proteins.
