Trial document





This trial has been registered retrospectively.
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  DRKS00006012

Trial Description

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Title

Influence of mitochondrial DNA on immune function in sepsis: a prospective observational trial

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Trial Acronym

mitochondrial DNA in sepsis

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URL of the Trial

http://none

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Brief Summary in Lay Language

Mitochondrial DNA (DNA from cell systems important for oxygen/energy metabolism) can be liberated from cells following severe polytrauma, and activates immune cells. However, it ist still unclear whether mitochondrial DNA can be found in the serum of patients with sepsis and whether mitochondrial DNA influences other immune cells as well.

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Brief Summary in Scientific Language

mitochondrial DNA stimulates neutrophils as reported by Zhang et al.. Furthermore, mitochondrial DNA can be found in the serum of patients with severe polytrauma. However, it is unclear whether mitochondrial DNA influences other immune cells as well, and if mitochondrial DNA can be found in the serum of septic patients. Thus, we want to test the hypotheses, that 1)mitochondrial DNA can be found in serum samples of patients with severe sepsis, and 2) mitochondrial DNA is a predictor for legality of sepsis. Furthermore, in mice the influence of mtDNA on the immune system shall be evaluated

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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

  •   DRKS00006012
  •   2014/07/11
  •   [---]*
  •   yes
  •   Approved
  •   063078, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   A41 -  Other sepsis
  •   R57.2 -  Septic shock
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Interventions/Observational Groups

  •   patients with severe sepsis on the first day of diagnosing sepsis. Patients characteristics were documented and blood was withdrawn for mtDNA analysis, cytokine measurements or genexpression analyses
  •   healthy volunteers without signs of infection were included and blood was withdrawn for mtDNA analysis, cytokine measurements and genexpression analyses
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   data analyst
  •   No treatment
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

serum concentration of mitochondrial DNA

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Secondary Outcome

30 day mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/01/01
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Sepsis as defined by Bone et al.

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Exclusion Criteria

Age < 18 yr.; mental disorder; patients who refused study participation

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Addresses

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    • Universitätsklinikum Essen
    • Mr.  PD Dr. med. MHBA  Simon  Schaefer 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Bonn
    • Mr.  Dr. rer.nat  Andreas  Limmer 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Essen
    • Mr.  PD Dr. med. MHBA  Simon   Schäfer 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen
    • Mr.  PD Dr. med.   Simon  Schäfer 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Mr.  PD Dr. med. MHBA  Simon  Schäfer 
    • Hufelandstraße 55
    • 45122  Essen
    • 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.