Different Lipid Emulsions in Acute Lung Injury Patients

July 19, 2016 updated by: B. Braun Melsungen AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Giessen, Germany, 35392
        • University clinic Giessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
i.v. lipid emulsion for parenteral nutrition
Drug: Lipoplus 20%
Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition
ACTIVE_COMPARATOR: 2
i.v. lipid emulsion for parenteral nutrition
Drug: Lipofundin N 20%
Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in blood oxygenation (PaO2/FiO2ratio)
Time Frame: change day 1 to day 6
change day 1 to day 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Triglycerides
Time Frame: day 1 to day 16
day 1 to day 16
Sequential Organ Failure Assessment
Time Frame: day 1 to day 28
day 1 to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (ESTIMATE)

March 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-G-H-0813
  • 2011-003397-82 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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