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

Sponsored by:	Li Shin Hospital
Information provided by:	Li Shin Hospital
ClinicalTrials.gov Identifier:	NCT00634075

Purpose

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.

Condition	Intervention	Phase
Severe Sepsis	Drug: omega-3-fatty acids (Omegaven) Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Lipids Fish oil

U.S. FDA Resources

Further study details as provided by Li Shin Hospital:

Primary Outcome Measures:

All cause mortality [ Time Frame: mortality rate on days 7 and 28. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Placebo Comparator	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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634075

Locations

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

Sponsors and Collaborators

Li Shin Hospital

Investigators

Principal Investigator:

Boon-Siang Khor, MD

Department of Emergency & Critical Care Medicine, Li Shin Hospital

More Information

No publications provided

Responsible Party:	Department of Emergency & Critical Care Medicine ( Boon-Siang Khor )
Study ID Numbers:	IRB-08-01
Study First Received:	March 4, 2008
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00634075 History of Changes
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Li Shin Hospital:

Severe sepsis
Proinflammatory cytokines
ICU

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Omega 3 Fatty Acid
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Infection
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009