Trial document




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  DRKS00009434

Trial Description

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Title

Frailty as prognostic factor of surviving liver transplantation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Since 1980, liver transplantation (LTX) is among the worldwide methods of choice for treating end-stage liver disease. The so-called MELD-score (Model for End-stage Liver Disease) is used to indicate the urgency of transplantation but it cannot specify its prospects of success. One construct possibly able to assess prospects of success of LTX is frailty. By means of frailty the mortality of patients awaiting liver transplantation could be predicted independently of the severity of the liver disease. Furthermore, it seems to influence the patients´quality of life. If, in this study, frailty is shown to be a prognostic factor of surviving LTX, the prospects of success of liver transplantation could be improved by conducting special intervention programs aiming at reducing frailty. Patients awaiting LTX will be investigated for frailty as well as for mental condition, cognitive ability, social support and quality of life by means of tests and questionnaires. Investigation is repeated every six months during waiting time and once 6 months after transplantation. A further group of patients is investigated once at least 12 months after LTX using the same tests and questionnaires. Research questions: 1. Can the prospects of success of LTX be predicted by the degree of frailty?, 2. What is the relationship between the different dimensions of frailty and the study parameters?, 3. How does frailty change during waiting time and after LTX?, 4. Which sociodemographic and physical variables characterize patients with end-stage liver disease? Are there any variables which influence fraility?

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Brief Summary in Scientific Language

The objective of this study is the investigation of the contribution of the construct of frailty to the success of a liver transplantation in addition to the MELD-score. Because the MELD-score does not include information on the prognosis after LTX, the consideration of a patients´ frailty for assessing the prospects of success or the convalescence after transplantation could lead to an information gain. Several studies point at the influence of frailty on mortality and quality of life of patients with end-stage liver disease previously to liver transplantation. In these studies, the MELD-score has been investigated as a covariate but it did not show any predictive value. Therefore, this study considers the question whether a patients´frailty is associated with LTX success and whether this construct is a prognostic factor independent of the MELD-score.

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Organizational Data

  •   DRKS00009434
  •   2015/12/09
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  •   yes
  •   Approved
  •   15-6604-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   K70-K77 -  Diseases of liver
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Interventions/Observational Groups

  •   Patients waiting for liver transplantation because of end-stage liver disease who come to LTX-consultation in the department of general, visceral and transplantaion surgery of the university hospital in Essen. Patients are investigated for frailty as well as for mental condition, cognitive ability, social support and quality of life by means of tests and questionnaires. Investigation is repeated every six months during waiting time and once 6 months after LTX. A further group of patients is investigated once at least 12 months after LTX in the same way.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

mortality 30 days after liver transplantation

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Secondary Outcome

complications within 30 days after LTX: time of being in intensive care, time of being given artificial respiration, infections, early allograft dysfunction, number of transfusions and administration of coagulation factors

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/01/07
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

diagnoses of end-stage liver disease or LTX at least 12 months ago, age between 18 and 80 years, good knowledge of the German language, willing to participate in the study

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Exclusion Criteria

physical or mental disability, severe psychiatric illness, severe hepatic encephalopathy or crucial critical flicker frequency, insufficient knowledge of the German language, bedriddenness

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Addresses

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    • Klinik für Psychosomatische Medizin und Psychotherapie, LVR-Klinikum Essen
    • 45147  Essen
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie, LVR-Klinikum Essen
    • Mr.  PD. Dr.  Sefik  Tagay 
    • Virchowstr. 174
    • 45147  Essen
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie, LVR-Klinikum Essen
    • Mr.  PD. Dr.  Sefik  Tagay 
    • Virchowstr. 174
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychosomatische Medizin und Psychotherapie, LVR-Klinikum Essen
    • 45147  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/14
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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.