Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011661

Trial Description

start of 1:1-Block title

Title

Influence of genetic variants on the outcome of critically ill patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Genetic variants in ICU patients

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Genetic variants may impact on the outcome from various diseaeses. Thus, we now analyze the influence of genetic variants on the ouctome /survival of the critically ill

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Genetic variants can be independent predictors for patients outcome from various diseaes. Thus, we now analyze the influence of single nucleotide polymorphisms (SNPs) on the outcome of critically ill patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011661
  •   2017/03/09
  •   [---]*
  •   yes
  •   Approved
  •   06-3078, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   A41.9 -  Sepsis, unspecified
  •   J80.0 -  [generalization J80: Adult respiratory distress syndrome]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Critically ill patients treated on an ICU with /without Sepsis or acute respiratory distress syndrome shall be included in this study.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Aim of this study is to analyze the 30 day mortality depending on genetic variants in ICU patients. Patients are enrolled in this study when first diagnosing Sepsis /ARDS or when they are admitted to ICU. Patients who are alive on day 30 are considered "survivors". In patients who die, the day after study enclosure is documented.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Disease severity as defined by ICU scores, like the simplified acute physiology score II (SAPS II).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/01/01
  •   500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

ICU therapy, mechanical ventilation

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

mental disorder, immunosuppression

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
    • Mr.  PD Dr. med.  Simon  Schäfer 
    • Hufelandstraße 55
    • 45122  Essen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
    • Mr.  PD Dr. med.  Simon  Schäfer 
    • Hufelandstraße 55
    • 45122  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
    • Mr.  PD Dr. med.  Simon  Schäfer 
    • Hufelandstraße 55
    • 45122  Essen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/12/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.