Trial document




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  DRKS00006754

Trial Description

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Title

Incidence and risk factors of viral infections in patients after 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

Today in specialized hospitals, liver transplantation are routine operations in case of severe chronic liver diseases. As a result of the following immunosuppression, these patients own a higher risk for viral infections. Known is that in case of a viral infection the risk for graft fail is clearly increased. That’s why liver-transplanted patients receive a prophylaxis with antiviral 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 viral infections in liver transplanted patients. In the same time the determination of risk factors and prognostic parameter will take place to perhaps decrease the risk of graft failure. The earlier detection and estimation of an invasive viral infection in liver- transplanted patients can help to develop new therapeutic strategies and to better indicate the necessity of an antiviral prophylaxis to increase the patient’s outcome.

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Brief Summary in Scientific Language

The orthotopic liver transplantation is a routinely used procedure to give patients with acute liver failure 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. For viral infection in liver-transplanted patients it is know, that they are associated with a worse outcome.
That’s why normally an antiviral 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 viral infections in liver transplanted patients and to find a differentiation between harmless colonization and invasive infection. Further prognostic parameter should be found to determinate the risk for viral infections in liver transplanted patients to elevate the patient’s outcome.
Clinical laboratory parameter like the kinetic of the liver enzymes, liver synthesis parameter and the relevant clinical scores (MELD, SOFA, APACHE II) will be examined. For the viral diagnostics antigenes, serological parameters (immunoglobulins) and PCR for viral-DNA will be executed. The earlier detection and estimation can help to determine the necessity of a antiviral 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

  •   DRKS00006754
  •   2014/09/17
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  •   yes
  •   Approved
  •   S-336/2014, 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
  •   K74.6 -  Other and unspecified cirrhosis of liver
  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
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Interventions/Observational Groups

  •   80 patients with 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 (leucocytes, CRP, PCT, temp.), inflammatory monitoring (sCD14-ST, AChE, IL-6, TNF-alpha), general laboratory testing, hemodynamic (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 regularly the MELD, APACHE II, SOFA, Child-Pugh -scores. The indication of a viral infection will be made by PCR of HSV- and CMV-DNA from throat swab and blood serum, detection of the speficic antibodies and the antigens from blood serum and the detection of pp65 from peripheral leucocytes. In intubated/tracheotomated patient’s tracheal secretion will be also used to perform HSV-and CMV-DNA-PCR.
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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 and progress of viral infections in patients with liver transplantation. The determination of the initial viral findings and the course by using ELISA- and PCR-methods (Polymerase Chain Reaction) for HSV (herpes simplex virus) and CMV (Cytomegalovirus) detection from blood plasma. The effectiveness of an antiviral prophylaxis to prevent invasive viral infection will also be determined.

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Secondary Outcome

Estimation of the validity of scoring systems (APACHE II, SOFA, MELD) and clinical laboratory parameters for the prognosis of viral infection in liver transplanted patients. Development of a scoring system to estimate the infection risk and to reduce the over-treatment. Evaluation of acetylcholinesterase and butyrilcholinesterase as new marker for synthesis performance of the new donor organ or as preterm infection parameter.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/03
  •   80
  •   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 consent
• 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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    • Heidelberger Stiftung Chirurgie
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • 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.