Back to resultsClinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Primary Purpose
Severe Sepsis
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
omega-3-fatty acids (Omegaven)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Severe Sepsis focused on measuring Severe sepsis, Proinflammatory cytokines, ICU
Eligibility 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.
Sites / Locations
- Li Shin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
All cause mortality
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00634075
Brief Title
Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Official Title
Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Li Shin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
Severe sepsis, Proinflammatory cytokines, ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
omega-3-fatty acids (Omegaven)
Other Intervention Name(s)
Omegaven
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
All cause mortality
Time Frame
mortality rate on days 7 and 28.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boon-Siang Khor, MD
Organizational Affiliation
Department of Emergency & Critical Care Medicine, Li Shin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Shin Hospital
City
Pingjen
State/Province
Taoyuan County
ZIP/Postal Code
32405
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
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