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

Phase 4

Completed

• Conditions: Severe Sepsis
• Interventions: Drug: omega-3-fatty acids (Omegaven); Drug: placebo

• Registration Number: NCT00634075
• Lead Sponsor: Li Shin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-12
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	omega-3-fatty acids (Omegaven)	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
All cause mortality	mortality rate on days 7 and 28.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Li Shin Hospital; 🇨🇳 Pingjen, Taoyuan County, Taiwan