Different Lipid Emulsions in Acute Lung Injury Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parenteral Nutrition

Intervention / Treatment
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* Drug: Lipoplus 20%
* Drug: Lipofundin N 20%


Participation Criteria
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Eligibility Criteria
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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 :

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>i.v. lipid emulsion for parenteral nutrition | Drug: Lipoplus 20%<br>* Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition<br>|
| Active Comparator: 2<br>i.v. lipid emulsion for parenteral nutrition | Drug: Lipofundin N 20%<br>* Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood oxygenation (PaO2/FiO2ratio) |  | change day 1 to day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides |  | day 1 to day 16 | 
| Sequential Organ Failure Assessment |  | day 1 to day 28 |