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Different Lipid Emulsions in Acute Lung Injury Patients

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B. Braun

Status and phase

Terminated
Phase 4

Conditions

Parenteral Nutrition

Treatments

Drug: Lipofundin N 20%
Drug: Lipoplus 20%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01814956
HC-G-H-0813
2011-003397-82 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 :

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1 participants in 2 patient groups

1
Experimental group
Description:
i.v. lipid emulsion for parenteral nutrition
Treatment:
Drug: Lipoplus 20%
2
Active Comparator group
Description:
i.v. lipid emulsion for parenteral nutrition
Treatment:
Drug: Lipofundin N 20%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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