Effect of delayed CNI-based immunosuppression with Advagraf® on liver function after MELD-based liver transplantation [IMUTECT]

BMC Surgery

Peter Schemmer²  Markus K Diener²  Colette Dörr-Harim⁴  Anja Sander³  Thomas Giese¹  Philipp Houben²  Daniel N Gotthardt⁵  Georg Polychronidis²  Susanne Richter² 

[1] Immunology, University of Heidelberg, Heidelberg, Germany;Department of General, Visceral and Transplant Surgery, Heidelberg, Germany;Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany;Study Centre of the German Surgical Society (SDGC), Heidelberg, Germany;Department of Internal Medicine IV, University of Heidelberg, Heidelberg, Germany

关键词: Immunostatus;    HLA-DR status;    Infection rate;    LiMAx test;    Liver function;    MELD-score;    Prospective observational study;    Advagraf®;   

Others  :  1118334
DOI  :  10.1186/1471-2482-14-64

 received in 2013-11-11, accepted in 2014-08-20,  发布年份 2014

【 摘 要 】

Background

MELD-based allocation for liver transplantation follows the “sickest-patient-first” strategy. The latter patients present with both, decreased immune competence and poor kidney function which is further impaired by immunosuppressants.

Methods/Design

In this prospective observational study, 50 patients with de novo low-dose standard Advagraf®-based immunosuppression consisting of Advagraf®, Mycophenolat-mofetil and Corticosteroids after liver transplantation will be evaluated. Advagraf® trough levels of 7-10 μg/l will be reached at the end of the first postoperative week. Immunostatus, infectious complications, graft and kidney function are compared between patients with a pretransplant calculated MELD-score of ≤20 and >20. Each group comprises of 25 consecutive patients. Prior to liver transplantation and on the postoperative days 1, 3 and 7, the patients’ graft function (LiMAx test) will be evaluated. On the postoperative days 3, 5 and 7 the patients’ immune status will be evaluated by the measurement of their monocytic HLA-DR status.

Infectious complications (CMV-reactivation, wound infection, urinary tract infection, and pneumonia), graft- and kidney function will be analysed on day 0, within the first week, and 1, 3, 6, 9 and 12 months after liver transplantation.

Discussion

This study was designed to assess the effect of a standard low-dose Calcineurin inhibitor-based immunosuppression regime with Advagraf® on the rate of infectious complications, graft and renal function after liver transplantation.

Trial registration

The trial is registered at “Clinical Trials” (http://www.clinicaltrials.gov webcite), NCT01781195.

【 授权许可】

   
2014 Richter et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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