Status:
COMPLETED
Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Lead Sponsor:
Li Shin Hospital
Conditions:
Severe Sepsis
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
The 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 se...
Eligibility Criteria
Inclusion
- Patients admitted to Li Shin Hospital's ICU with a main diagnosis of severe sepsis.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00634075
Start Date
March 1 2008
End Date
August 1 2009
Last Update
August 13 2009
Active Locations (1)
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1
Li Shin Hospital
Pingjen, Taoyuan County, Taiwan, 32405