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Completed

NCT Number: NCT00634075

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.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Li Shin Hospital

Pingjen, Taoyuan County, 32405, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Omegaven

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.

Primary outcomes

  1. All cause mortality

    Time frame: 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.

    Time frame: Days 0, 1, 3, 5, 7, 14 and 28.

Sponsors and collaborators

Lead sponsor

Li Shin Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 12, 2008
Registry last updated
Aug 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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