Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00014629

Trial Description

start of 1:1-Block title

Title

Extracorporeal membrane oxygenation in adults: a retrospective analysis of differences in indication, morbidity and mortality in a single-centre observational study.

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

Trial Acronym

no acronym is used

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

URL of the Trial

http://no URL is used

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

Brief Summary in Lay Language

Extracorporal membrane oxygenation ("heart-lung machine") is an accepted treatment option in patients with acute lung failure. Moreover, patients with cardiogenic and septic shock are treated with this regimen. The results of this retropective observational study presents in detail surviving data and specifies predictors of prognosis. Moreover, a learning curve for the intervention is demonstrated.

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

Brief Summary in Scientific Language

We retrospectively analysed the data of 131 patients undergoing ECMO treatment in the intensive care unit of the Asklepios Hospital Langen over the time period from April 2011 to July 2016. We categorized the patients into three groups according to their indication: Lung failure (n=54); cardiogenic shock (n=58); and septic shock (n=19). The primary target variable was hospital mortality; the secondary target variables were identification of prognostic variables before using ECMO on lethality. Hospital mortality continues to be as high as ever at over 50% for all indication groups. Taking the identified influence variables into account could help when defining indications and as such may help contribute to an improvement in results.

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

Organizational Data

  •   DRKS00014629
  •   2018/04/20
  •   [---]*
  •   yes
  •   Approved
  •   FF 88/2017, Ethikkommission der Landesärztekammer Hessen
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

  •   R57.0 -  Cardiogenic shock
  •   R57.2 -  Septic shock
  •   J80 -  Adult respiratory distress syndrome
  •   Extracorporal membrane oxygenation
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Study participants are patients with ARDS (=Acute Respiratory Distress Syndrome) (n=54). The duration of the ECMO (Extracorporal membrane oxygenation) therapy depends primarily on cardiovascular parameters and on the blood oxygenation. Primary endpoint is in-hospital mortality.
  •   Study participants are patients with cardiogenic shock (n=58). The duration of the ECMO therapy depends primarily on cardiovascular parameters and on the blood oxygenation. Primary endpoint is in-hospital mortality.
  •   Study participants are patients with septic shock (n=19). The duration of the ECMO therapy depends primarily on cardiovascular parameters and on the blood oxygenation. Primary endpoint is in-hospital mortality.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Historical, Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

mortality

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

Secondary Outcome

Prognostic factors just before ECMO for mortality

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

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/11/20
  •   131
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

ARDS (Acute Respiratory Distress Syndrome); cardiogenic shock; septic shock; retrospective analysis of all patients treated in the Asklepios Klinik Langen with ECMO from April 2011 til July 2016.

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

Exclusion Criteria

not applicable

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Asklepios Klinik Langen
    • Mr.  Dr  Alexander  Buia 
    • Röntgenstr 20
    • 63225  Langen
    • 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 other
    • Asklepios Klinik Langen
    • Mr.  Prof  Hans-Bernd  Hopf 
    • Röntgenstr 20
    • 63225  Langen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Asklepios Klinik Langen
    • Mr.  Dr  Alexander  Buia 
    • Röntgenstr 20
    • 63225  Langen
    • 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
    • Asklepios Klinik langen
    • Mr.  Dr  Alexander  Buia 
    • Röntgenstr 20
    • 63225  Langen
    • 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
    • Asklepios Klinik Langen
    • Mr.  Dr  Alexander  Buia 
    • Röntgenstr 20
    • 63225  Langen
    • 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
  •   2018/01/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

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