BMC Surgery | |
Effect of delayed CNI-based immunosuppression with Advagraf® on liver function after MELD-based liver transplantation [IMUTECT] | |
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 |
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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.
【 预 览 】
Files | Size | Format | View |
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20150206022823306.pdf | 272KB | download | |
Figure 1. | 47KB | Image | download |
【 图 表 】
Figure 1.
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