Trial document





This trial has been registered retrospectively.
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  DRKS00016584

Trial Description

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Title

Survival of ECMO therapy in adipose and morbidly obese patients

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Trial Acronym

ECMO OBESE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Extracorporeal membrane oxygenation for therapy or support of critical acute respiratory distress syndrom or heart failure is growing in its availabilty. With this option, more and more patients are potential candidates for this. The relative contraindications against ECMO include excessive bodyweight above 150kgs. However, there is no conclusive evidence for discriminating against bodyweight. In this study, we plan to examine the influence of bodyweight and body mass index (BMI) on mortality of patients with ECMO support.

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Brief Summary in Scientific Language

Extracorporeal membrane oxygenation (ECMO) as therapy support for acute respiratory distress syndrome (ARDS) or heart failure is undergoing a renaissance with a wider availability. Due to technological improvements and better biocompatibility of membranes, more experience for clinical users, it is now not only an option for most advanced medical centres. This increase in experience led to a continous relaxation of relative contraindications. However, an increased bodyweight >150kg is still considered the upper limit by many centres. Despite a growing body of evidence showing feasibility of performing ECMO in obese patients, there are no larger cohort data evaluating the impact of body mass index (BMI) on ECMO mortality. In this study data from ECMO patients from our centre from the years 2013-2018 will be analysed in regard to: in house mortality, ICU length of stay, hospital length of stay, ECMO parameters, disease severity and comorbidities . Furthermore, predicted mortality using RESP/SAVE/REMEMBER Scores will be compared to observed mortality matched with BMI.

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Organizational Data

  •   DRKS00016584
  •   2019/01/31
  •   [---]*
  •   yes
  •   Approved
  •   201/18, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J80.0 -  [generalization J80: Adult respiratory distress syndrome]
  •   I27.9 -  Pulmonary heart disease, unspecified
  •   E66 -  Obesity
  •   I26 -  Pulmonary embolism
  •   I21 -  Acute myocardial infarction
  •   J10 -  influenza due to identified seasonal influenza virus
  •   ECMO
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Interventions/Observational Groups

  •   patients with normal BMI and ECMO support, retrospective analyses of epidemiological data, DMI, length of stay (hospital), length of stay (ICU), days on ECMO, days on mechanical ventilation, SOFA, SAVE, RESP Score, ECMO mode, ECMO parameters, SAPS II, TISS, Charlson Comorbidity Index (CCI), Mortality.
  •   preadipose patients with ECMO support, retrospective analyses of epidemiological data, DMI, length of stay (hospital), length of stay (ICU), days on ECMO, days on mechanical ventilation, SOFA, SAVE, RESP Score, ECMO mode, ECMO parameters, SAPS II, TISS, Charlson Comorbidity Index (CCI), Mortality.
  •   Patients with BMI>30 and ECMO support, retrospective analyses of epidemiological data, DMI, length of stay (hospital), length of stay (ICU), days on ECMO, days on mechanical ventilation, SOFA, SAVE, RESP Score, ECMO mode, ECMO parameters, SAPS II, TISS, Charlson Comorbidity Index (CCI), Mortality.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

inhouse mortality

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Secondary Outcome

predicted vs. observed mortality after ECMO, duration of mechanical ventilation, ECMO duration, lenght of stay ICU, hospital length of stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/01
  •   350
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with vv- or va-ECMO

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Exclusion Criteria

Age<18years

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Addresses

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin,Universitätsklinikum Bonn
    • Mr.  Dr.med.  Stefan  Ehrentraut 
    • Sigmund-Freud-Straße 25
    • 53105  Bonn
    • Germany
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    • Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin,Universitätsklinikum Bonn
    • Mr.  Dr.med.  Jens-Christian  Schewe 
    • Sigmund-Freud-Straße 25
    • 53105  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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