Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration MedDRA version: 16.1 Level: PT Classification code 10069351 Term: Acute lung injury System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Lipidem 20 % (Germany)
Pharmaceutical Form: Emulsion for infusion
Other descriptive name: soy bean oil
Concentration unit: % percent
Concentration type: equal
Concentration number: 8-
Othe
Sponsors
B. Braun Melsungen AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 ( 300 mg/dl at screening, Alterations of coagulation (thrombocytes 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 days (5 treatments) have been provided. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety variables: GOT, GPT, GGT, AP, total & direct bilirubin, lipase, triglycerides, cholesterol, blood glucose, sodium, potassium, calcium, phosphorus, albumin, total protein, lactate, creatinine, urea, uric acid, CBC, INR, aPTT, Hospital Anxiety and Depression Score (HADS), AE reporting Efficacy variables: length of ICU & hospital stay, days free of (28 day timeframe): ICU care, ventilation, sedation, catecholamine, renal replacement therapy, rate of ICU complications, SOFA score, 28 & 90 day mortality, Special variables: free fatty acid profile (AA, LA, ALA, DHA, EPA) and total plasma fatty acids, apoptosis/proliferation markers of lymphocytes, cytokine (TNF, IL-6, IL-8, IL-10), Th-17 cell, LTB4, LTB5, resolvins (RvE1, NPDn) Other variables: weight, height, BMI, nutritional requirements & intake by parenteral and enteral nutrition, concomittant therapy, Insulin, demographic data, primary & secondary diagnosis, medical & medication history, vital signs; first 24 hrs of ICU: APACHE II, GCS, SAPS II;Timepoint(s) of evaluation of this end point: Safety variables: daily, day 1 to day 16 (see above, except for HADS); AE documentation daily Efficacy variables: daily, exept SOFA score until day 16 daily; mortality day 28, day 90 For special variables: day 1, 4, 6, 16 Others: PN and EN intake daily | — |
Countries
Germany
Contacts
Public ContactClinical Development, Hospital Care
B. Braun Melsungen AG
Outcome results
None listed