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

NCT ID: NCT00634075

Last Updated: 2009-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-08-31

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.

Conditions

Severe Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

omega-3-fatty acids (Omegaven)

Intervention Type: DRUG

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.

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Omegaven

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Shin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of Emergency & Critical Care Medicine

Principal Investigators

Boon-Siang Khor, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency & Critical Care Medicine, Li Shin Hospital

Locations

Li Shin Hospital

Pingjen, Taoyuan County, Taiwan

Countries

Taiwan

Other Identifiers

IRB-08-01

Identifier Type: -

Identifier Source: org_study_id