Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: omega-3-fatty acids (Omegaven)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: omega-3-fatty acids (Omegaven)<br>* 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.<br>* Other names: Omegaven;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | mortality rate on days 7 and 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe sepsis, Proinflammatory cytokines, ICU