Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008342

Trial Description

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Title

Jena Sepsis Registry - a Sepsis-registry for Long Term Outcomes

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Trial Acronym

JenaSepsisReg

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis
management are recognized. Investigators present a population-based registry with easy
feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of
the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or
septic shock). Baseline data on ICU- and hospital care will be extracted from patient
records at ICU discharge. The primary outcome is change in all-cause mortality from baseline
to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data
will be collected from the primary care provider of the patient. The registry may provide
valid data on quality in sepsis care.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00008342
  •   2016/03/11
  •   2014/06/11
  •   yes
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Secondary IDs

  •   NCT02165501  (ClinicalTrials.gov)
  •   3218-08/11  (University of Jena)
  •   FZ 01 E0 1002 
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Health Condition or Problem studied

  •   Severe Sepsis or Septic Shock (ICD-10-GM, R65.0, R65.1)
  •   R65.0 -  Systemic Inflammatory Response Syndrome of infectious origin without organ failure
  •   R65.1 -  Systemic Inflammatory Response Syndrome of infectious origin with organ failure
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- all cause mortality; time frame: change from baseline to 6,12, 24, 36, 48 and 60 months after ICU discharge; based on data from hospital records as well as patient records of the primary care provider.

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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

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  •   2011/01/31
  •   2000
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients treated in one of the ICUs will be enrolled if they were 18 years or older
and fulfill the diagnostic criteria of severe sepsis or septic shock (ICD-10-GM,
R65.0, R65.1) (19), (20).

- Diagnosis of severe sepsis or septic shock requires the following criteria: a
microbiologically documented and/or clinically evident infection, at least two of the
four criteria of the systemic inflammatory response syndrome (SIRS) and at least one
new organ dysfunction, remote from the site of infection.

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Exclusion Criteria

-

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Jena
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  • start of 1:1-Block address scientific-contact
    • Jochen Gensichen 
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Jochen Gensichen 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2015/05/04
* This entry means the parameter is not applicable or has not been set.