Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009827

Trial Description

start of 1:1-Block title

Title

Is there a parameter that allows to predict survival following out-of-hospital cardiac arrest at the time of hospital admission?

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

Trial Acronym

[---]*

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

[---]*

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

Brief Summary in Scientific Language

Different parameters have been discussed to predict survival following out-of-hospital cardiac arrest (OHCA). However, non of them allows to predict survival at the time of hospital admission, as for example blood parameter like Neuron Specific Enolase increases with a delay of > 24 hours.
Therefore, it is common practice to focus on the first pH value to predict the patient`s prognosis. Nevertheless, there is no study at that time, that tried to find out, whether the first pH is the most suitable parameter, or whether other parameters in the blood gas analysis might have a better prognostic worth.
We therefore retrospectively identified all victims from OHCA, who were admitted to our hospital between January 1st 2008 and December 31st 2013 and identified the first arterial blood gas analysis in their medical records to find out which parameter of the blood gas analysis has the highest prognostic worth for survival.

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

Organizational Data

  •   DRKS00009827
  •   2016/01/21
  •   [---]*
  •   yes
  •   Approved
  •   4889-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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

  •   I46.1 -  Sudden cardiac death, so described
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   All victims of out-of-hospital cardiac arrest will be identified and the first arterial blood gas analysis will be gathered from the medical records. Afterwards, the different parameters of the first blood gas analysis will be researched to find out, which parameter might have the best prognostic value with regard on survival following out-of-hospital cardiac arrest.
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
  •   Prognosis
  •   Single (group)
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

5 days survival

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

Secondary Outcome

survival until hospital discharge

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

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

Recruitment

  •   Actual
  •   2014/02/07
  •   204
  •   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

out-of-hospital cardiac arrest

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

Exclusion Criteria

Age < 18 years, pregnancy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum
    • Mr.  Dr.  Martin  Christ 
    • Hölkeskampring 40
    • 44625  Herne
    • 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
    • Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum
    • Mr.  Dr.  Martin  Christ 
    • Hölkeskampring 40
    • 44625  Herne
    • 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
    • Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum
    • Mr.  Dr.  Martin  Christ 
    • Hölkeskampring 40
    • 44625  Herne
    • 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
    • Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum
    • Mr.  Dr.  Martin  Christ 
    • Hölkeskampring 40
    • 44625  Herne
    • 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
  •   2015/12/31
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.