Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01814956
Eligibility 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 :
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01814956
Study Brief:
Protocol Section:
NCT01814956