RANDOMIZED CONTROLLED TRIAL OF THE EFFECTS OF PARENTERAL FISH OIL EMULSION IN CRITICALLY ILL SEPTIC PATIENTS IN THE INTENSIVE CARE UNIT
- Conditions
- Sepsis
- Registration Number
- EUCTR2009-016880-13-GB
- Lead Sponsor
- IVERSITY HOSPITALS OF LEICESTER NHS TRUST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 74
All critically Ill septic patients in the intensive care unit between age 18 and 90 and without exclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
The following will be excluded from the trial:
•Planned ITU/HDU admission post elective surgery.
•Hypersensitivity to fish, egg or soy protein.
•Uncontrolled hyperlipidaemia
•Severe primary blood coagulation disorder
•Acute pancreatitis accompanied with hyperlipidaemia
•Ketoacidosis
•Acute thromboembolic disease
•Severe liver failure
•Acute phase of myocardial infarction or stroke
•Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The effect of Omega 3 fatty acids on reduction of APACHE II score as a surrogate marker of mortality.;Secondary Objective: • Progression of care from level 2 to level3<br>• Down staging of care from level 3 to level 2, or level 2 to level 1<br>• Mortality rate<br>• Length of hospital stay<br>• Time intubated<br>• Inotrope requirements<br>• Organ support (filter)<br>• Return to pre-morbid function<br>• Changes in inflammatory makers C-reactive protein, White Blood Cell Count (WBC), total protein/albumin<br>• Measured ?-3/6 FA levels and ratios in cellular membranes of blood leukocytes to confirm uptake<br>• Change in serum leucotrienes, pAF, interleukin, PGE2, LT-4, TNFa, IL-1 and IL6. Plus other inflammatory markers;Primary end point(s): Lowering APACHE II score
- Secondary Outcome Measures
Name Time Method