Severe Sepsis
Conditions
Keywords
Severe sepsis, Proinflammatory cytokines, ICU
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 severe sepsis.
Interventions
DRUGomega-3-fatty acids (Omegaven)
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.
DRUGplacebo
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.
Sponsors
Li Shin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality | mortality rate on days 7 and 28. |
Secondary
| Measure | Time frame |
|---|---|
| Lengths of ICU and hospital stay. Duration of mechanic ventilator requirement. Serial changing APACHE II and SOFA score. Changing of TNF-α, IL- 1β, IL-6, IL-8, and IL-10 levels. Incidence of hospital-acquired infection. | Days 0, 1, 3, 5, 7, 14 and 28. |
Countries
Taiwan
Outcome results
None listed