Liver transplantation
Conditions
Interventions
Experimental group:Model guidance +Therapeutic drug monitoring (TDM)
Control group:Experience administration +Therapeutic drug monitoring (TDM)
Sponsors
Xiang'an Hospital, Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years; 2.Patients receiving tacrolimus based immunosuppressive regimen; 3.Voluntary test and sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Multiple organ transplantation; 2.Secondary organ transplantation; 3.Diagnosed with immune disorders or other diseases requiring immune-related treatment after LT; 4.Conditions known to seriously affect the metabolism of tacrolimus (such as plan to use diltiazem, posaconazole, fluconazole, erythromycin or undergo renal dialysis immediately after LT); 5.Has contraindications of tacrolimus; 6.Fail to definitively diagnose for diabetes preoperatively; 7.Patients who participate in other investigational drug trials; 8.Or any scenarios that investigators consider not appropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion in range (PIR): the proportion of patients with tacrolimus blood trough concentration falling within the TCR (PIR) (4-10 ng/ml) 24 hours after the initial dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of post-transplantation diabetes mellitus (PTDM) at 6 months;Numbers of dose adjustment;First time to achieve target concentration range (TCR);Proportion in range (PIR) within 7 days;Incidence of post-transplantation diabetes mellitus (PTDM) at 3,9,12 months;Incidence of new-onset IFG and FBG at 3, 6, 9, 12 months after surgery;Mortality after liver transplantation;Recurrence rate of hepatocellular carcinoma with standards of UCSF or Milan after LT during the follow-up period;The incidence of acute rejection is confirmed by biopsy during the follow-up period;Other safety outcomes such as the incidence of infection, tacrolimus-related kidney injury, biliary stricture or bile leakage during the follow-up period; | — |
Countries
China
Contacts
Public ContactPeng Zhihai
Xiang'an Hospital, Xiamen University
Outcome results
None listed