Trial document





This trial has been registered retrospectively.
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  DRKS00004264

Trial Description

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Title

Identification of hepatological and metabolical risk factors in patients with a ventricular assist device

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with end stage heart failure often have secondary end organ dysfunction, in particular the liver. During the course of the ventricular assist device implantation the liver function can diminish further. This can lead to serious complications associated with prolonged stay in the intensive care unit. The aim of this observational study is, therefore, to identify potential parameters which reflect the actual hepatic function before and after the implantation of the ventricular assist device. In this context we want to determine parameters which predict a complicated and/or prolonged postoperative course before the implantation. Furthermore, we want to identify parameters which show impairement of the hepatic function at an early stage. Therefore we will assess different clinical parameters from every patient before the implantation and at different time points after the device has been implanted. The data will be collected in a database until they are analyzed.

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Brief Summary in Scientific Language

Identification of pre- and post-operative risk factors for liver dysfunction in the course of ventricular assist device implantation.

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Organizational Data

  •   DRKS00004264
  •   2014/03/28
  •   [---]*
  •   yes
  •   Approved
  •   1129-2011, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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

  •   Therapy refractory heart failure
  •   Z95.80 -  [generalization Z95.8: Presence of other cardiac and vascular implants and grafts]
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Interventions/Observational Groups

  •   Patients with terminal heart failure who have an indication for the implantation of a ventricular assist device.
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Characteristics

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

Survival after 100 days

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Secondary Outcome

Liver dysfunction defined as bilirubin >51 µmol/l, Albumin <28 g/l, ICG-PDR <10 %/min on POD 3 and 7.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/10/27
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with an indication for the implantation of a ventricular assist device, written informed consent of the patient or a legally certain attendant

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Exclusion Criteria

no indication for the implantation of a ventricular assist device, missing informed consent

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr. med.  Andrea  Schneider 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr. med.  Andrea  Schneider 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/31
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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.