Status:
TERMINATED
Different Lipid Emulsions in Acute Lung Injury Patients
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Parenteral Nutrition
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 comparis...
Eligibility Criteria
Inclusion
- 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 :
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01814956
Start Date
March 1 2013
End Date
May 1 2015
Last Update
July 20 2016
Active Locations (1)
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1
University Clinic Giessen
Giessen, Germany, 35392