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
Lipoplus 20%
+ Lipofundin N 20%
Signs and Symptoms+1
+ Signs and Symptoms, Digestive
+ Pathological Conditions, Signs and Symptoms
Treatment Study
Summary
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1 patient to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 :
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location