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

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.

Study Overview

• Status: Completed
• Conditions: Severe Sepsis
• Intervention / Treatment: Drug: omega-3-fatty acids (Omegaven); Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan County
    • Pingjen, Taoyuan County, Taiwan, 32405
      • Li Shin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: omega-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.; Other Names: Omegaven
Placebo Comparator: 2	Drug: placebo; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Li Shin Hospital
• Investigators: Principal Investigator: Boon-Siang Khor, MD, Department of Emergency & Critical Care Medicine, Li Shin Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: March 4, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 12, 2008

Study Record Updates

• Last Update Posted (Estimate): August 13, 2009
• Last Update Submitted That Met QC Criteria: August 12, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: ICU; Severe sepsis; Proinflammatory cytokines
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: IRB-08-01