Trial document





This trial has been registered retrospectively.
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  DRKS00006131

Trial Description

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Title

A randomized controlled, single-blinded pilot study to investigate the effect of lipid emulsions on alveolar leukocyte recruitment in volunteers after endotoxin-inhalation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

It is the aim of the study to gain insight into the differential influence of a soybean-oil (omega-6 fatty acid) and fish-oil (omega-3 fatty acid) –based parenteral nutrition on leukocyte function in healthy volunteers. Both compounds are approved medical products for intravenous nutrition. After application of a common dosage of lipid emulsions, we intend to isolate leukocytes and analyze their inflammatory capacity. In addition, the incorporation of fatty acids into the cell membrane of leukocytes will be investigated, as well as the spectrum of fatty acids in the plasma. Background of this study is a differential anti-inflammatory effect shown in experimental and clinical studies and the clinical need of parenteral nutrition of critically ill patients. In former times, fatty acids required for lipid emulsions were produced from vegetable oils. Newly, formulations are available which were generated out of fish oil. Until now data is missing on the impact of these novel lipid emulsions on the inflammatory capacity of leukocytes.

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Brief Summary in Scientific Language

Lipid emulsions are considered as an essential component of clinical parenteral nutrition regimens applied to critically ill patients. Besides providing adequate caloric support, several studies indicate immunomodulatory properties of lipid emulsions, as shown by their ability to alter cytokine release, to modify leukocyte function, and to influence the generation of lipid mediators that display both pro- and anti-inflammatory properties. Currently, there is a paucity of data on the impact of intravenous lipid emulsions on patient with pulmonary injury. As a pilot study, we intend to investigate the differential effect of a conventional soybean-oil based lipid emulsion, containing large amount of omega-6 fatty acids, versus a novel fish-oil containing formulation, supplying omega-3 fatty acids in an endotoxin-inhalation model with healthy volunteers. Data from literature suggests a pronounced anti-inflammatory effect of fish-oil in comparison to soybean-oil in other disease models. As a read-out parameter we will investigate to effect of the respective lipid infusions on alveolar leukocyte function, inflammatory capacity, and incorporation of fatty acids in the cell membrane.

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Organizational Data

  •   DRKS00006131
  •   2014/05/14
  •   [---]*
  •   yes
  •   Approved
  •   71/01, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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Health Condition or Problem studied

  •   J80 -  Adult respiratory distress syndrome
  •   healthy participants
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Interventions/Observational Groups

  •   Infusion of 350ml of a 10% fish oil-based lipid emulsion on day 1 and day 2 over a period of 12h each. Inhalation of endotoxin (individuel dose)
  •   Infusion of 350ml of a 10% soybean oil-based lipid emulsion on day 1 and day 2 over a period of 12h each. Inhalation of endotoxin (individuel dose)
  •   Infusion of 350ml of a NaCl 0.9% on day 1 and day 2 over a period of 12h each. Inhalation of endotoxin (individuel dose)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Placebo, Active control
  •   Basic research/physiological study
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

Leukocytes in broncho-alveolar lavage 8 or 24 h after inhalation

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Secondary Outcome

Cytokines in broncho-alveolar lavage 8 or 24h after endotoxin inhalation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2001/10/01
  •   42
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria


Healthy adults

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Exclusion Criteria

Hyperreactive bronchial system
Pregnancy
Allergy against study medication

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Addresses

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    • Medizinische Klinik II, Universitätsklinikum Gießen und Marburg
    • Mr.  Prof. Dr.  Konstantin  Mayer 
    • Klinikstr. 33
    • 35392  Gießen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Medizinische Klinik II, Universitätsklinikum Gießen und Marburg
    • Mr.  Prof. Dr.  Konstantin  Mayer 
    • Klinikstr. 33
    • 35392  Gießen
    • Germany
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    • Medizinische Klinik II, Universitätsklinikum Gießen und Marburg
    • Mr.  Prof. Dr.  Konstantin  Mayer 
    • Klinikstr. 33
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2003/03/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.