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

BMC Surgery

Study Protocol

Susanne Richter¹  Peter Schemmer¹  Markus K Diener¹  Philipp Houben¹  Georg Polychronidis¹  Daniel N Gotthardt²  Thomas Giese³  Anja Sander⁴  Colette Dörr-Harim⁵ 

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

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

DOI  :  10.1186/1471-2482-14-64

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

来源: Springer

【 摘 要 】

BackgroundMELD-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/DesignIn 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.DiscussionThis 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 registrationThe trial is registered at “Clinical Trials” (http://www.clinicaltrials.gov), NCT01781195.

【 授权许可】

Unknown   
© Richter et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.