Trial with two lipid emulsions already approved for artificial nutrition to evaluate possible differences in 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: Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration; MedDRA version: 16.1Level: PTClassification code 10069351Term: Acute lung injurySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-003397-82-DE
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Acute Lung Injury (ALI) as a result of proven pneumonia (x-ray) or wittnessed aspiration,
PaO2/FiO2 = 300 or less,
less than 72 hours since intubation or non-invasive ventilatory support by mask at screening,
expected need for parenteral nutrition for at least 5 days
full care on ICU,
male or female,
18 years of age or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cardiogenic pulmonary oedema,
Previous or ongoing need for corticosteroid therapy with more than 0.1mg/kg /day prednisolon-equivalent or other immune-suppressive treatment,
Previous (< 1 year) or active treatment for solid or haematologic malignancy,
Serum Triglycerides > 300 mg/dl at screening,
Alterations of coagulation (thrombocytes < 100 Giga/l), aPTT > 60 sec, INR equal or > than 2.5 without therapeutic intevention,
Parenteral nutrition with SMOF or Omegaven,
Enteral nutrition with Pulmocare, Oxepa or Impact (any variety),
Autoimmune disease or HIV,
Known or suspected drug abuse,
Hypersensitivity to egg, fish, or soya-bean protein or to any of the active substances or excipients,
Severe renal failure without access to haemofiltration or dialysis,
Severe liver failure with bilirubin > 2.5 mg/dL,
Acute phase of myocardial infarction or stroke before timely scheduled interventional treatment and stabilization,
Acute thromboembolic disease until stabilization,
Lipid embolism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the impact of a parenteral nutrition regimen including a fish oil-enriched lipid emulsion on the pulmonary function in patients with Acute Lung Injury;Secondary Objective: To investigate safety and further efficacy variables of a fish oil-containing i.v. lipid emulsion as part of intensive care treatment;Primary end point(s): Change in blood oxigenation (PaO2/FiO2) from day 1 to day 6;Timepoint(s) of evaluation of this end point: Day 1 before parenteral nutriton started and day 6 in the morning after 5<br>days (5 treatments) have been provided.