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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634075
• Other study ID #: IRB-08-01
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2008
• Last updated: August 12, 2009
• Start date: March 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Li Shin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Li Shin Hospital	Pingjen	Taoyuan County

Sponsors (1)

Lead Sponsor	Collaborator
Li Shin Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		mortality rate on days 7 and 28.	No
Secondary	Lengths of ICU and hospital stay. Duration of mechanic ventilator requirement. Serial changing APACHE II and SOFA score. Changing of TNF-a, IL- 1ß, IL-6, IL-8, and IL-10 levels. Incidence of hospital-acquired infection.		Days 0, 1, 3, 5, 7, 14 and 28.	No