Different Lipid Emulsions in Acute Lung Injury Patients

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG

Criteria

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 :