Trial document




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  DRKS00000647

Trial Description

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Title

Multidimensional mass-spectrometry for early detection of severe sepsis/septic shock in patients with neutropenic fever – a pilot study.

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Trial Acronym

Lab-ALERTS pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of the study is the identification of novell blood markers for early diagnosis of severe sepsis/septic shock (infectious blood poisoning) in patients with neutropenia (very low white blood cells). Multidimensional mass-spectroscopy, an analytical technique that measures the mass-to-charge ratio of charged particles, is used for identification of these new markers.

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Brief Summary in Scientific Language

Identification of diagnostic signatures for early diagnosis of severe sepsis / septic shock by multidimensional mass-spectroscopy (SELDI-TOF) in patients with neutropenic fever

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Organizational Data

  •   DRKS00000647
  •   2010/12/15
  •   [---]*
  •   yes
  •   Approved
  •   2970-11/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   Förderkennzeichen BMBF  ( 01 E0 1002)
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Health Condition or Problem studied

  •   A41.9 -  Septicaemia, unspecified
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Interventions/Observational Groups

  •   Asservation of excess blood from routine blood sample during hospital stay. Analysis of blood samples before fever, at fever onset and following 4 days with masspectroscopy (SELDI-TOF).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Identification of diagnostic signatures for early diagnosis of severe sepsis / septic shock

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Secondary Outcome

Assessing the prognostic value of newly identified molecular signatures in patients at high risk of developing severe sepsis/septic shock in comparison to currently available, conventional laboratory parameters and clinical risk factors

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/12/10
  •   120
  •   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

Patients with haemato-oncological disease
undergoing chemotherapy with anticipated period of neutropenia which agree to participate in the study

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Exclusion Criteria

none

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Addresses

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    • Institut für Klinische Chemie und Laboratoriumsdiagnostik Center for Sepsis Control and Care (CSCC) Klinikum Lobeda
    • Mr.  Dr. med. Dr. rer. nat.  Michael  Kiehntopf 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Institut für Klinische Chemie und Laboratoriumsdiagnostik Center for Sepsis Control and Care (CSCC)
    • Mr.  Dr. med. Dr. rer. nat.  Michael  Kiehntopf 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Institut für Klinische Chemie und Laboratoriumsdiagnostik Center for Sepsis Control and Care (CSCC) Klinikum Lobeda
    • Mr.  Dr. med. Dr. rer. nat.  Michael  Kiehntopf 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Heinemannstr 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.