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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00634075
Other study ID # IRB-08-01
Secondary ID
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


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
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