Trial document




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  DRKS00000065

Trial Description

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Title

Modification of leukocyte activation status during sepsis-induced acute renal failure.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

During acute renal failure, e.g. due to blood poisoning (sepsis), metabolites and toxins accumulate in the blood (uraemia). Up to now effects of uremia on leukocyte activation are unknown. Leukocytes are part of the innate and adaptive immune system. Therefor they are involved in inflammation and defend the body against pathogenic bacteria. The analysis of leukocytes via flow chamber assays - to check interactions of leukozytes with immobilized proteins - and other assays (e.g. flow cytometry) will provide first indications of effects of uremia on leukocyte activation status. These results will provide important advice for the clinical managemant of acute renal failure.

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Brief Summary in Scientific Language

During acute renal failure metabolites and toxins accumulate in the blood (uraemia). These metabolites and toxins can have an effect on recruitment of leukocytes to sites of infection. The aim of this study is to analyse activation of leukocytes due to metabolites and toxins during uremia.

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Organizational Data

  •   DRKS00000065
  •   2009/01/12
  •   [---]*
  •   yes
  •   Approved
  •   2008-171-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   Sepsis
  •   acute renal failure
  •   N17 -  Acute renal failure
  •   A41.9 -  Septicaemia, unspecified
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Interventions/Observational Groups

  •   sepsis
    1) diagnosis:
    analysis of neutrophil activation by flow chamber and flow cytometry
    2) therapy:
    purpose of this trial is not therapy but observation
  •   sepsis and acute renal failure:
    1) diagnosis:
    analysis of neutrophil activation by flow chamber and flow cytometry
    2) therapy:
    purpose of this trial is not therapy but observation
  •   healthy test persons:
    1) diagnosis:
    analysis of neutrophil activation by flow chamber and flow cytometry
    2) therapy:
    purpose of this trial is not therapy but observation
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
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  •   Basic research/physiological study
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

analysis of neutrophil activation status via flow chamber and flow cytometry after asservation of samples

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2009/02/01
  •   60
  •   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

sepsis (Anonymous, Crit Care Med 1992, 20:864-874):
1. At least two oft he following parameters:
a) hypothermia (core temperature <36°C) or fever (>38.3°C)
b) tachycardia with heart rate > 90 beats per minute
c) tachypnea wit >= 20 breaths per minute and/or paCO2 <= 32 mmHg or mechanical ventilation d) leucopenia (WBC < 4,000 cells/µl) or leukocytosis (WBC count >12,000 cells/µl) or normal WBC count with > 10 % immature forms
AND
2. Infection, documented or suspected,

acute renal failure (RIFLE, Bellomo, Critical Care 2004, 8:R204-R212):
1. increase of serumcreatinine x 3 compared to initial value (e.g. within the last 7 days)
OR
2. urine output < 0,3 ml/kg/h for 24 hours or anuria for 12 hours

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Exclusion Criteria

age < 18 years
gravidity
immunsupressive therapy (within the last 7 days)
chronic renal failure (eGFR < 60 l/min)
known haematologic disease
known HIV-infection

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Addresses

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    • Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin Universitätsklinikum Münster
    • Albert-Schweitzer-Str. 33
    • 48149  Münster
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    •   0251/83-47255
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    •   [---]*
    •   [---]*
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    • Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin Universitätsklinikum Münster
    • Mr.  Dr. med.  Alexander  Zarbock 
    • Albert-Schweitzer-Str. 33
    • 48149  Münster
    • Germany
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    • Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin Universitätsklinikum Münster
    • Mr.  Dr. med.  Alexander  Zarbock 
    • Albert-Schweitzer-Str. 33
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft 53170 Bonn
    • Deutsche Forschungsgemeinschaft 
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    •   0228/885-1
    •   0228/885-2777
    •   [---]*
    •   http://www.dfg.de
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Status

  •   Recruiting planned
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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.