Trial document




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  DRKS00005480

Trial Description

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Title

Mycotic findings in patients after liver transplantation – Invasive mycosis or harmless colonization?

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Today in specialized hospitals, liver transplantations are routinely performed in case of severe chronic as well as acute liver diseases. As a result of the following immunosuppression, these patients own a higher risk for mycotic infections. Known is that in case of a mycotic infection the risk for graft failure is clearly increased. That’s why liver-transplanted patients receive a prophylaxis with antimycotic medicaments. These medicaments have unwished side effects and cannot prevent infections in all patients.
The presented study has the goal to indicate the incidence of mycotic infections in liver transplanted patients and to define distinctive features between a harmless colonization and an invasive infection. At the same time the determination of risk factors and prognostic parameters will take place in order to decrease the risk of graft failure. The earlier detection and estimation of an invasive mycotic infection in liver-transplanted patients may help to develop new therapeutic strategies and to better indicate the necessity of an antimycotic prophylaxis in order to optimize the patient’s outcome.

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Brief Summary in Scientific Language

The orthopic liver transplantation is a routinely used procedure to give patients with acute liver fail or severe chronic liver diseases the chance to survive. The innovations of the last years gave them the possibility to have a longer life in combination with a higher quality of life.
In some cases primary and secondary graft failure can occur and leads to the necessity of a re-transplantation or patient’s death. In terms of mycotic infections in liver-transplanted patients it is know, that they are associated with a worse outcome. That’s why normally an antimycotic prophylaxis is given, but these medicaments are associated with unwished side effects and cannot prevent infections in every case.
The goal of the presented study is to indicate the incidence of mycotic infections in liver transplanted patients and to define distinctive features between harmless colonization and invasive infection. Further prognostic parameters should be found to determinate the risk for mycotic infections in liver transplanted patients to optimize the patient’s outcome.
Clinical laboratory parameters like the kinetic of the liver enzymes, liver synthesis parameters and the relevant clinical scores (MELD, SOFA, APACHE II) will be examined. For the mycotic diagnostics fungal cultures, the serological parameters (Galactomannan and 1,3-ß-D-Glucan) and PCR for fungal-DNA will be executed. The earlier detection and estimation can help to determine the necessity of an antimycotic prophylaxis and to develop new therapy strategies to minimize the risk for a graft failure or patient’s death.

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Organizational Data

  •   DRKS00005480
  •   2013/11/26
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  •   yes
  •   Approved
  •   S-098/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   Patients undergoing orthotopic liver transplantation from deceased donors
  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   K74.6 -  Other and unspecified cirrhosis of liver
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Interventions/Observational Groups

  •   100 patients following liver transplantation will be included. The following parameters will be screened on day 0-1-2-7-14-21-28 after transplantation: Anamnesis (acute/chronic), general infectiology (leukocytes, CRP, PCT, temp.), inflammatory monitoring (sCD14-ST, AChE, IL-6, TNF-alpha), general laboratory testing, hemodynamic parameters (MAP, HR, CVP, CI, SVR, PVR) & need for catecholamines, ventilation ((FiO2, AMV, AF, VT, PEEP), blood gazes, bilancing, metabolism, organ failure, general and immunosupressive medication and determination of the MELD, APACHE II, SOFA, Child-Pugh -scores. The indication of a fungal infection will be made by fungal culture, detection of the speficic antibodies and the antigens galactomannan and (1,3)-ß-d-glucan from blood serum and the direct fungal detection by PCR. In intubated/tracheotomated patient’s tracheal secretion will be also used to perform Candida- and Aspergillus-PCR and fungal cultures.
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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

Incidence, risk factors and progress of mycotic infections in patients with liver transplantation.

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Secondary Outcome

Assessment of the additional benefit of a next-generation sequencing (NGS)-based diagnostic approach, the diagnostic value of ß-D-glucan (BG), galactomannan (GM), interferon gamma (INF-γ), tumor necrosis factor alpha (TNF-α), interleukins (IL)-2, -4, -6, -10, -17A and mid-regional proadrenomedullin (MR-proADM) for the diagnosis of an invasive fungal disease

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/08
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Liver transplantation at the center of transplantation in Heidelberg
• Written and signed informt consens
• Age > 18 years

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Exclusion Criteria

Non-Compliance to the including criteria’s

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Addresses

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Sources of Monetary or Material Support

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    • Klinik für Anaesthesiologie Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Stefan  Hofer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • B.Braun-Stiftung
    • 34209  Melsungen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/03/14
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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.