Trial document




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  DRKS00001149

Trial Description

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Title

Measurement of adhesion molecules (sVCAM, SICAM, sE-selectin) in pediatric patients with lung failure

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Measurement of transmitters of severe pulmonary failure in children

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Brief Summary in Scientific Language

lung failure in children isa relevant factor for a the mortalitiy in pediatric intensive care patients. adhesion molecules are representing the endothelial damage and play a role on the vascular side of lung failure. adhesion molecule are expressed short after an inflammatory stimulus occured and are responsible for the contact of blood cells to the wall of the vessel and for the extravasation of these cells to the origin of inflammation. the sheded or soluble forms of the adhesion molecules are detectable in the blood. In certain situation the role of adhesion molecules (i.e. VCAM in chest syndromes of patients with sickle cell anemia) are beter understood. VCAM can suppress the function of the NO Synthetasis and therfore aggravate the oxygenation problems. We will measure in different types of pediatric lung failure the serum levels of adhesion molecules to analyse wether adhesion molecules play an role in these situations.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00001149
  •   2011/12/30
  •   2005/09/15
  •   yes
  •   Approved
  •   204/04, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF000516  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   J80 -  Adult respiratory distress syndrome
  •   A41.9 -  Septicaemia, unspecified
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Interventions/Observational Groups

  •   adhesion molecules in patients with iNO therapy
  •   adhesion molecule levels in patients without iNO therapy
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Prognosis
  •   Parallel
  •   N/A
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Primary Outcome

prognosis of lung failure according to the adehesion molecule levels (measure by oxygenation index, days on 1,0 Fio2, days on ventilation)

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Secondary Outcome

prognosis of multiorgan failure according to the adehesion molecule levels

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2012/02/20
  •   26
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   15   Years
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Additional Inclusion Criteria

age 1 - 15 years
intubation or NIV
paO2 / Fio2 < 300 (> 3 hours)
arterial line

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Exclusion Criteria

Vitium cordis
bone marrow transplantation (or intended)
planned surgical intervention during study period

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Addresses

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    • Universitätsklinikum Freiburg Zentrum für Kinderheilkunde und Jugendmedizin
    • Mathildenstraße 1
    • D-79106  Freiburg
    • Germany
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    • ZKJ, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med  Marcus  Krüger 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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    • ZKJ, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med  Marcus  Krüger 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • ZKJ, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med  Marcus  Krüger 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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