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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01814956

Enrollment

Registered

2013-03-20

Start date

2013-03-31

Completion date

2015-05-31

Last updated

2016-07-20

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

Conditions

Parenteral Nutrition

Brief 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.

Interventions

DRUGLipoplus 20%

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

DRUGLipofundin N 20%

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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 :

Design outcomes

Primary

Measure	Time frame
change in blood oxygenation (PaO2/FiO2ratio)	change day 1 to day 6

Secondary

Measure	Time frame
Triglycerides	day 1 to day 16
Sequential Organ Failure Assessment	day 1 to day 28

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026