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Different Lipid Emulsions in Acute Lung Injury Patients

Primary Purpose

Parenteral Nutrition

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Lipoplus 20%
Lipofundin N 20%
Sponsored by
B. Braun Melsungen AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parenteral Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 :

Sites / Locations

  • University Clinic Giessen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

i.v. lipid emulsion for parenteral nutrition

i.v. lipid emulsion for parenteral nutrition

Outcomes

Primary Outcome Measures

change in blood oxygenation (PaO2/FiO2ratio)

Secondary Outcome Measures

Triglycerides
Sequential Organ Failure Assessment

Full Information

First Posted
March 18, 2013
Last Updated
July 19, 2016
Sponsor
B. Braun Melsungen AG
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1. Study Identification

Unique Protocol Identification Number
NCT01814956
Brief Title
Different Lipid Emulsions in Acute Lung Injury Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenteral Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
i.v. lipid emulsion for parenteral nutrition
Arm Title
2
Arm Type
Active Comparator
Arm Description
i.v. lipid emulsion for parenteral nutrition
Intervention Type
Drug
Intervention Name(s)
Lipoplus 20%
Intervention Description
Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition
Intervention Type
Drug
Intervention Name(s)
Lipofundin N 20%
Intervention Description
Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition
Primary Outcome Measure Information:
Title
change in blood oxygenation (PaO2/FiO2ratio)
Time Frame
change day 1 to day 6
Secondary Outcome Measure Information:
Title
Triglycerides
Time Frame
day 1 to day 16
Title
Sequential Organ Failure Assessment
Time Frame
day 1 to day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 :
Facility Information:
Facility Name
University Clinic Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany

12. IPD Sharing Statement

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Different Lipid Emulsions in Acute Lung Injury Patients

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