Different Lipid Emulsions in Acute Lung Injury Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-05-31

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.

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Detailed Description

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Conditions

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Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

i.v. lipid emulsion for parenteral nutrition

Group Type EXPERIMENTAL

Lipoplus 20%

Intervention Type DRUG

Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition

2

i.v. lipid emulsion for parenteral nutrition

Group Type ACTIVE_COMPARATOR

Lipofundin N 20%

Intervention Type DRUG

Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition

Interventions

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Lipoplus 20%

Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition

Intervention Type DRUG

Lipofundin N 20%

Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 :

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No