Trial document





This trial has been registered retrospectively.
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  DRKS00013285

Trial Description

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Title

Clinical relevance of bacteraemia with vancomycin-resistant enterococcus vs. vancomycin-sensible enterococcus in patients after orthotopic 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

Bacterial infections after liver transplantation are very common, particularly in the early postoperative phase. They are a major cause of death in this early stage. Multidrug resistant organisms (MDR) as a potential source are not uncommon. Patients after liver transplantation are at risk for bacteremia with enterococcus species. We want to explore to what extend the course of illness differs between a bacteremia with vancomycin-resistant enterococcus spp (VRE) and vancomycin-sensible enterococcus spp (VSE).
Therefore we will conduct a single Center, retrospective cohort Study at the University Hospital of Heidelberg, Germany and will include all patients above the age of 18 who became a orthotopic liver Transplantation and suffered from a bloodstream infection with VRE or/and VSE between 01/01/2007 and 12/31/2016.

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Brief Summary in Scientific Language

The orthotopic liver transplantation (OLT) is often the only curative treatment for different end stage liver diseases. Despite advanced operative techniques, interdisciplinary management and better immunosuppressive therapy, these patients are still at high risk for complications. Viral and bacterial infections play a great role here. Bacterial infections occur particularly in the early stage after liver transplantation and are one of the major cause of death. Multidrug resistant organisms (MDR) as a potential source are not uncommon at this stage. Patients after liver transplantation are at risk for bacteremia with enterococcus species. The prevalence of vancomycin-resistant enterococcus spp (VRE) has increased in the last years, not only international, but especially in Germany. Therefore, the portion of bacteremia due to VRE in liver transplant patients has risen in Heidelberg as well. Enterococcus spp are relatively low virulent and low pathogen compared to staphylococcus spp i.e. When it comes to a bacteremia caused by enterococcus spp it is a different story. Enterococcus spp are the most common pathogenic agents causing nosocomial bacteremia. To date it is not definitely clear whether the sensitivity or the resistance against vancomycin respectively, influence the treatment result of a bacteremia with enterococcus spp. Most of the studies focusing on this topic originate from a time where effective antibiotics, most notably linezolid, were not yet available. Not surprising these studies concluded a negative impact for the outcome of these patients, given the before mentioned limitations. Based on these findings extensive recommendations were published in 2006 with the purpose to contain the spread of VRE. These unrevised recommendations suggest isolation precautions for affected patients, which lead to mental stress for these patients and complicate the treatment of such. Data based on today’s treatment options are lacking to show if a vancomycin-resistance in case of a bacteremia with enterococcus spp actually increases the risk of an unfavorable treatment course; particularly for the group which is most affected from bacteremia due to VRE, patients after liver transplantation. As one of the biggest centres for liver transplantations in Germany we want to test to what extent the patients’ outcome differs after OLT within 30 days after occurrence of a blood stream infection with enterococcus faecium and how much these outcomes are influenced by the vancomycin resistance. For this purpose, we conduct a retrospective data analysis and we will study and record potential differences in the treatment courses from patients after LOT and BSI (Blood stream infection) with vancomycin sensible and vancomycin resistant Enterococcus faecium isolates. Outcome parameter are mortality and the course of the SOFA (Sequential Organ Failure Assessment) Scores within 30 days after the begin of the BSI. To adjust both groups we must not only include demographic date, but also the initial severity of disease and we will incorporate more data (i.e. numbers of invasive procedures) to characterize the treatment course.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013285
  •   2018/03/13
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  •   yes
  •   Approved
  •   S-407/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   Orthotopic liver transplantation, Bacteremia, vancomycin resistant enterococcus, vancomycin sensible enterococcus, multidrug resistant pathoge, enterococcus spp, Mortalität
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Interventions/Observational Groups

  •   Retrospective, monocentric cohort study. Inclusion criteria: Age > 18 years, orthotopic liver Transplantation and VSE-BSI between 01/01/2007 and 12/31/2016. Follow-up for 30 days after onset of bacteremia.

  •   Retrospective, monocentric cohort study. Inclusion criteria: Age > 18 years, orthotopic liver Transplantation and VRE-BSI between 01/01/2007 and 12/31/2016. Follow-up for 30 days after onset of bacteremia.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Are patients after OLT (orthotopic liver transplantation) within 30 days after blood stream infection with vancomycin resistant enterococcus at higher risk to die compared to patients with vancomycin sensible enterococcus?

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Secondary Outcome

1. Is the hospital stay of OLT patients after a blood stream infection with vancomycin resistant enterococcus longer then after a blood stream infection with vancomycin sensible enterococcus?
2. Are patients after OLT within 30 days after a bacteremia with vancomycin resistant enteroccous at higher risk of multi organ failure then patients with a bacteremia with vancomycin sensible enterococcus?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/10/02
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

All patients above the age of 18 who got a orthotopic liver transplantation and suffered from a bloodstream infection with VRE or/and VSE between 01/01/2007 and 12/31/2016.

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Exclusion Criteria

Age < 18 years and not fullfill inclusion criteria

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Zentrum für Infektiologie – Medizinische Mikrobiologie und HygieneUniversitätsklinikum Heidelberg
    • Ms.  Prof.  Alexandra  Heininger 
    • Im Neuenheimer Feld 324
    • 69120  Heidelberg
    • Germany
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    • Klinik für AnästhesiologieUniversitätsklinikum Heidelberg
    • Mr.  PD  Thorsten  Brenner 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für AnästhesiologieUniversitätsklinikum Heidelberg
    • Mr.  PD  Thorsten  Brenner 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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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.