None listed
Conditions
Brief summary
Patients who undergo liver transplant surgery have a significant incidence rate of infection by Cytomegalovirus, also known a CMV. This virus is responsible for decreased liver function and transplant failure. In this study, we will monitor CMV infection in liver transplant patients. Monitoring of patients will be performed by laboratory tests and will help determine the best way to prevent and treat CMV infection/disease. Researchers around the world have used various strategies to reduce the incidence of CMV infection/disease in liver transplant patients. These include laboratory tests for detecting CMV as a guide to administering intravenous ganciclovir (pre-emptive therapy) or preventative therapy by giving patients oral valganciclovir from time of transplantation (prophylaxis).
Interventions
High risk group and prophylaxis group are assigned to receive 900mg (two 450mg tablets) of valganciclovir (Valcyte) once daily for 3 months commenced within 72 hrs after liver transplantation and monitored regularly for CMV infection/disease. Dose will be changed based on creatinine clearance.
Pre- Emptive group Monitored regularly for CMV infection only. If this occurs patients will be given 5 mg/kg intravenously over one hour, of ganciclovir (GCV) twice daily for 2 weeks CMV infection is det
High risk group and prophylaxis group are assigned to receive 900mg (two 450mg tablets) of valganciclovir (Valcyte) once daily for 3 months commenced within 72 hrs after liver transplantation and monitored regularly for CMV infection/disease. Dose will be changed based on creatinine clearance. Pre- Emptive group Monitored regularly for CMV infection only. If this occurs patients will be given 5 mg/kg intravenously over one hour, of ganciclovir (GCV) twice daily for 2 weeks CMV infection is determined on testing with Qualitative Polymerease chain reaction (PCR) Valganciclovir doses as per creatinine clearance: Creatinine clearance >/=60 ml/min 900mg daily Creatinine clearance 40-59 ml/min 450mg daily Creatinine clearance 25-39 ml/min 450mg second daily Creatinine clearance 10-24 ml/min 450 mg twice weekly
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female > 16 years of age 2. Patients undergoing liver transplantation 3. Single or multi-organ transplant 4. Patients meet transplant criteria 5. Chronic liver disease or fulminant hepatic failure 6. Able to give written informed consent
Exclusion criteria
1. Patients under the age of 16 years 2. History of hypersensitivity to ganciclovir or valganciclovir 3. Patients involved in any other clinical trials 4. Patients taking any other investigational drugs within 2 months prior to the study screening. 5. Use of any other antiviral therapy against herpes virus within 2 months prior to transplant will be noted and this population analysed as a subgroup 6. Patients unable to give consent 7. Inadequate renal function defined as creatinine clearance < 10 mL/sec
Outcome results
None listed