Different Lipid Emulsions in Acute Lung Injury Patients

Parenteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01814956
• Other study ID #: HC-G-H-0813
• Secondary ID: 2011-003397-82
• Status: Terminated
• Phase: Phase 4
• First received: March 18, 2013
• Last updated: July 19, 2016
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Parenteral Nutrition
• Respiratory Distress Syndrome, Adult

Intervention

Drug:
• Lipoplus 20%
Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition
• Lipofundin N 20%
Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition

Locations

Country	Name	City	State
Germany	University Clinic Giessen	Giessen

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in blood oxygenation (PaO2/FiO2ratio)		change day 1 to day 6	No
Secondary	Triglycerides		day 1 to day 16	Yes
Secondary	Sequential Organ Failure Assessment		day 1 to day 28	No