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

Li Shin Hospital

Status and phase: Completed; Phase 4

Conditions: Severe Sepsis

Treatments: Drug: omega-3-fatty acids (Omegaven); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00634075

IRB-08-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: omega-3-fatty acids (Omegaven)

2

Placebo Comparator group

Treatment:

Drug: placebo