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

• Sponsor: Li Shin Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00634075
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis	Drug: omega-3-fatty acids (Omegaven); Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. All cause mortality [mortality rate on days 7 and 28.]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00634075
• Other Study ID Numbers: IRB-08-01
• First Posted: Mar 12, 2008
• Last Update Posted: Aug 13, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Severe sepsis; Proinflammatory cytokines; ICU
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Aug 13, 2009