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

NCT00634075 | Completed Phase 4 DMC

• 1 other identifier: IRB-08-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Severe sepsis; Proinflammatory cytokines; ICU

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  mortality rate on days 7 and 28.

Secondary Outcomes (1)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: omega-3-fatty acids (Omegaven)

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

omega-3-fatty acids (Omegaven) 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.

Also known as: Omegaven

1

placebo 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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to Li Shin Hospital's ICU with a main diagnosis of severe sepsis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Shin Hospital: lead

Study Sites (1)

Li Shin Hospital

Pingjen, Taoyuan County, 32405, Taiwan

Location

MeSH Terms

Conditions

Sepsis

Interventions

Docosahexaenoic Acids; fish oil triglycerides

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Boon-Siang Khor, MD

  Department of Emergency & Critical Care Medicine, Li Shin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 13, 2009

Record last verified: 2009-08

Locations

TW (1)