Different Lipid Emulsions in Acute Lung Injury Patients

Prospective, Randomized, Controlled, Double-blind, Parallel-group, Mono-center, Explorative Phase IV Trial on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion Versus a Standard Soybean-oil Based Lipid Emulsion in Patients With Acute Lung Injury

Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung injury.

Inclusion:

• Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration
• Oxygenation factor ≤ 300
• <= 72 hours since intubation or non-invasive ventilatory support by mask at screening
• Expected need for parenteral nutrition for at least 5 days
• Male or female ≥ 18 years of age

Exclusion:

• Exclusion of pregnancy in women with child-bearing potential
• Cardiogenic pulmonary oedema
• Previous (< 1 month) or ongoing need for corticosteroids >0.1 mg/kg/d prednisolon-equivalent or other immune suppressive treatment
• Active or previous (< 1 year) treatment for solid or haematologic malignancy
• Serum triglycerides > 300 mg/dl at screening
• Alterations of coagulation (thrombocytes <100 Giga/l), aPTT > 60 sec, INR ≥ 2.5 without therapeutic intervention
• Autoimmune disease or HIV (according to medical history)
• Known or suspected drug abuse
• General contraindications to infusion therapy :