Trial document




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  DRKS00016505

Trial Description

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Title

Prospective, descriptive, observational study at the end of life of patients with extracorporeal membrane oxygenation in Germany

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Trial Acronym

ECMO-EoL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

With the help of a heart-lung-machine (extracorporeal membrane oxygenation (ECMO) therapy), it is possible to support or even to replace the lung or heart function of a severe ill patient at an intensive care unit for a limited period of time until full recovery or - in extreme cases- until successful organ transplantation. Mortality of patients on heart-lung-machine remains unchanged on a high level in Germany. High mortality of patients under such a procedure and an increasing overall number of its application more often results in treatment situations with dying patients on a heart-lung-machine in intensive care units.
Aim of this observational study is to describe the actual end-of-life care situation of patients with heart-lung-machine treatment in Germany. With age, underlying disease, manner and length of heart-lung-machine treatment until death details should be found out to support the careful use of the risky and expensive treatment. A detailed description of the way of finding the patient`s will and the determination the treatment goal and an analysis of strengths and weaknesses of the actual end-of-life care should help to work out recommendations to improve the quality of care of these critical ill patient and their relatives and simultaneously give the members of the treatment team assistance in dealing with described, emotionally stressful situations in daily work on an intensive care unit. The participants of the study are patients and the medical staff of the involved centers of the ARDS network Germany (http://ardsnetzwerk.de/ueber-das-netzwerk/beteiligte-einrichtungen/). All deceased patients in the observed period in the participating centers should be included, if the patients were treated with the heart lung machine until dying. All actual reported 85 members of the ARDS network Germany are asked for participation. A weekly request is planned over a period of six months (February - July 2019) with online questionnaires. Data collection is made anonymously. The responsible physician is filling in the individual online questionnaire for the deceased patient in the particular week of observation. The aim of the study is the description of a framework of end-of-life care, the decision-making-process for the use of the heart-lung-machine and the determination of the patient`s will and an analysis of the process to an end-of- life decision and, finally, the description of care while the patient is dying. Data are collected anonymously, an individual follow back for individual patient`s data or the data of the participating hospital is not possible, so informed consent for patients is not necessary. The participation of the medical centers is on a voluntary basis.

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Brief Summary in Scientific Language

With the help of extracorporeal membrane oxygenation (ECMO) therapy, it is possible to support or even to replace lung or heart function of a severe ill patient at an intensive care unit for a limited period of time until full recovery or - in extreme cases- until successful organ transplantation. Mortality of patients on ECMO therapy remains unchanged on a very high level in Germany. High mortality of patients with ECMO therapy and an increasing overall number ECMO runs on ICUs more often result in situation of dying patients on ECMO therapy on intensive care units. Aim of this observational study is to describe the actual end-of-life treatment situation of patients with ECMO therapy in Germany. Furthermore detailed analysis of strengths and weaknesses of the actual caring situation should be worked out. With age, underlying disease, mode and length of ECMO therapy until death details information should be gained to support the responsible use of the high invasive, risky and costly ECMO therapy procedures.
By analyzing the process of finding the patient`s will and of determining the goal of treatment and by the description of strengths and weaknesses of the actual end-of-life care recommendations should be developed to improve the quality of treatment for these critical ill patient and their relatives and simultaneously give the members of the ICU team assistance in dealing with described, stressful situations in daily work. The participants of the study are the patients and the medical staff of the involved centers of the ARDS network Germany (http://ardsnetzwerk.de/ueber-das-netzwerk/beteiligte-einrichtungen/). All deceased patients in the observed period of each single participating center should be included, if the patients were treated with ECMO therapy until dying.
All actual reported 85 members of the ARDS network Germany are asked for participation. A weekly request is planned over a period of six months (February - July 2019) with online questionnaires. Data collection is made anonymously. The responsible physician is filling in the individual online questionnaire for the deceased patient in the particular week of observation. The aim of the study is the description of the framework of caring and decision-making at the end of life of patients on ECMO therapy, the determination of the patient`s will, the analysis of the decision-making process and the care for the dying patient. Data are collected anonymously, an individual follow back on individual patient`s data or on the single participating hospital or ICU is not possible, so informed consent for patients is not necessary. The participation of the medical centers is on a voluntary basis.

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Organizational Data

  •   DRKS00016505
  •   2019/02/01
  •   [---]*
  •   yes
  •   Approved
  •   009/19-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   J80.03 -  [generalization J80: Adult respiratory distress syndrome]
  •   I50.14 -  [generalization I50.1: Left ventricular failure]
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Interventions/Observational Groups

  •   Observational study: evaluation with online questionnaires for physicians, which patient died under ECMO therapy.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

Evaluation of questionnaires collected from February till July 2019: presentation of a framework of care for patients with ECMO therapy.
Reasons and mode of ECMO therapy of the deceased patients. Initiators and participants in the process of
finding the patient`s will regarding ECMO therapy. Initiators and participants in the process of decision-making in end-of-life treatment situations of patients with ECMO therapy. Describing the situation of dying: Mode of reducing ECMO therapy, mode of sedation, participating relatives and ICU staff.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/02/01
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

patients with extracorporeal membrane oxygenation, who died

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Exclusion Criteria

none

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Addresses

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    • Universität Leipzig
    • Augustusplatz 10
    • 04109  Leipzig
    • Germany
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    •   0341 97 108
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    •   [---]*
    •   [---]*
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    • Klinik und Poliklinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr.med.  Falk  Fichtner 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr.med.  Falk  Fichtner 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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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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* This entry means the parameter is not applicable or has not been set.