Liver transplantation, acute rejection atfer liver transplantation. Liver transplant status
Conditions
Interventions
Intervention 1: Intervention group: Receiving Pearl Calcitriol 0.25 micrograms twice daily. Intervention 2: Control group: two pearl of placebo per-oral for one month.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients (18 years or older) undergoing liver transplantation from a brain-dead donor at Imam Khomeini Hospital, Tehran. Serum calcium less than 10.5 mg/dL Serum phosphorus level less than 6 mg/dL
Exclusion criteria
Exclusion criteria: Early allograft dysfunction, defined as: The presence of at least one of the following parameters: bilirubin greater than or equal to 10 mg/dL on day 7 after transplantation or INR greater than or equal to 1.6 on day 7 after transplantation or ALT or AST greater than 2000 IU/L on day 7 after transplantation. Primary allograft failure defined as: AST greater than 3000 IU/L with at least one of INR greater than 2.5, arterial pH less than 7.3 or venous pH less than 7.25, or serum lactate level greater than 4 mmol/L Not receiving the immunosuppression regimen mentioned (corticosteroid + calcineurin inhibitor + mycophenolate) in the Methods section.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute rejection. Timepoint: During first 3 months post liver transplantation. Method of measurement: The patient can, at the doctor's discretion, not undergo a biopsy and only be given a pulse corticosteroid. If the patient responds to pulse corticosteroid treatment and the enzymes decrease, it is defined as acute rejection with clinical suspicion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of time of first acute rejection episode between two groups. Timepoint: During first 3 months post transplant. Method of measurement: clinically suspicion which responds to corticostroid puls.;Comparison of incidence and kind of infection episodes between two groups. Timepoint: During 3 months post liver transplantation. Method of measurement: Clinical observation and laboratory findings.;Comparison of hospital stay during first hospitalisation post transplantation. Timepoint: During 3 months post liver transplantation. Method of measurement: Hospital documentation.;Comparison of patient survival and graft survival. Timepoint: During 3 months post liver transplantation. Method of measurement: Hospital documentation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSana Hamedani
Tehran University of Medical Sciences
Outcome results
None listed