RANDOMIZED CONTROLLED TRIAL OF THE EFFECTS OF PARENTERAL FISH OIL EMULSION IN CRITICALLY ILL SEPTIC PATIENTS IN THE INTENSIVE CARE UNIT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016880-13-GB

Enrollment

280

Registered

2010-03-17

Start date

2011-03-11

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Trade Name: Lipidem 200 mg/ml emulsion for infusion Product Name: Lipidem 200 mg/ml emulsion for infusion Product Code: Product A Pharmaceutical Form: Emulsion for infusion Trade Name: Lipofundin MCT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 • Down staging of care from level 3 to level 2, or level 2 to level 1 • Mortality rate • Length of hospital stay • Time intubated • Inotrope requirements • Organ support (filter) • Return to pre-morbid function • Changes in inflammatory makers C-reactive protein, White Blood Cell Count (WBC), total protein/albumin • Measured ?-3/6 FA levels and ratios in cellular membranes of blood leukocytes to confirm uptake • 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	—

Measure

Time frame

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 • Down staging of care from level 3 to level 2, or level 2 to level 1 • Mortality rate • Length of hospital stay • Time intubated • Inotrope requirements • Organ support (filter) • Return to pre-morbid function • Changes in inflammatory makers C-reactive protein, White Blood Cell Count (WBC), total protein/albumin • Measured ?-3/6 FA levels and ratios in cellular membranes of blood leukocytes to confirm uptake • 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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026