Trial document





This trial has been registered retrospectively.
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  DRKS00006111

Trial Description

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Title

Influence of the NFKB1 promotor polymorphism (-94ins/delATTG) on hydrocortisone effectiveness and mortality in septic shock

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Trial Acronym

NFKB and HC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A genetic variation in the NFKB gen( promoter polymorphism; -94ins/del ATTG) influences the mortality of septic patients and is associated with an increased inflammatory response in vitro. As deletion allele carriers have hyperinflammation, hydrocortisone administration in septic shock may influence patients mortality. Therefore, we conduct an observational trial to analyze the influence of hydrocortisone and the NFKB genotype on patients mortality in septic shock. Furthermore, in vitro we analyze the genotype dependent effect of hydrocortisone in the inflammatory response of immune cells. In detail, we want to analyze the influence of hydrocortisone in vitro in insertion genotype and deletion genotype individuals. Furthermore, we want to analyze in septic patients whether hydrocortisone influences patients mortality (Hydrocortisone therapy (group 1) vs. No hydrocortisone therapy(group 2)) in insertion genotype individuals and deletion allele carriers

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Brief Summary in Scientific Language

Deletion allele carriers of the NFKB promoter polymorphism -94ins/del ATTG have increased 30-day mortality in severe sepsis and are associated with an increased inflammatory response in vitro. As deletion allele carriers have hyperinflammation, hydrocortisone administration in septic shock may influence patients mortality. Therefore, we conduct an observational trial to analyze the influence of hydrocortisone and the NFKB genotype on patients mortality in septic shock. Furthermore, in vitro we analyze the genotype dependent effect of hydrocortisone on the NFkB nuclear translocation in myeloid cells.

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Organizational Data

  •   DRKS00006111
  •   2014/04/23
  •   [---]*
  •   yes
  •   Approved
  •   06-3078, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   A41.9 -  Sepsis, unspecified
  •   R57.2 -  Septic shock
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Interventions/Observational Groups

  •   patients with septic shock, who were treated with hydrocortisone due to the decision of the clinician are evaluated regarding 30 day mortality and severity of illness (SAPS II). Blood withdrawal for cytokine measurements will be performed on the day of diagnosing septic shock.
  •   patients with septic shock, who were NOT treated with hydrocortisone due to the decision of the clinician in charge are evaluated regarding 30 day mortality and severity of illness (SAPS II). Blood withdrawal for cytokine measurements will be performed on the day of diagnosing septic shock.
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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

30-day mortality

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/02/01
  •   160
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

septic shock

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Exclusion Criteria

age <18: refusal of study participation, non caucasian ethnicity

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
    • Mr.  PD Dr. med.  Simon  Schäfer 
    • Hufelandstraße 55
    • 45122  Essen
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
    • Mr.  PD Dr. med.  Simon  Schäfer 
    • Hufelandstraße 55
    • 45122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.