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Richter, S; Polychronidis, G; Gotthardt, DN; Houben, P; Giese, T; Sander, A; Dörr-Harim, C; Diener, MK; Schemmer, P.
Effect of delayed CNI-based immunosuppression with Advagraf® on liver function after MELD-based liver transplantation [IMUTECT].
BMC Surg. 2014; 14(6):64-64
Doi: 10.1186/1471-2482-14-64
[OPEN ACCESS]
Web of Science
PubMed
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- Leading authors Med Uni Graz
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Schemmer Peter
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- Abstract:
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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.
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.
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.
The trial is registered at "Clinical Trials" (http://www.clinicaltrials.gov), NCT01781195.
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Adolescent -
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Adult -
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Aged -
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Dose-Response Relationship, Drug -
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Drug Therapy, Combination -
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Female -
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Follow-Up Studies -
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Glucocorticoids - administration & dosage
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Glucocorticoids - therapeutic use
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Graft Rejection - immunology
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Graft Rejection - prevention & control
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Humans -
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Immunosuppression - methods
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Immunosuppressive Agents - administration & dosage
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Immunosuppressive Agents - therapeutic use
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Liver Transplantation -
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Male -
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Middle Aged -
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Mycophenolic Acid - administration & dosage
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Mycophenolic Acid - analogs & derivatives
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Mycophenolic Acid - therapeutic use
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Prospective Studies -
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Treatment Outcome -
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Young Adult -
- Find related publications in this database (Keywords)
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Advagraf (R)
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Prospective observational study
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MELD-score
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Liver function
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LiMAx test
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Infection rate
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HLA-DR status
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Immunostatus