None listed
Conditions
Brief summary
Decompensated cirrhosis is associated with high morbidity and mortality as well as high resource utilisation and healthcare costs. This study aims to provide evidence for a novel intervention to reduce hospitalisation in this vulnerable cohort. We hypothesise that continuous terlipressin infusion will be more effective than weekly albumin infusions in the prevention of decompensating liver events in cirrhosis
Interventions
Continuous terlipressin infusion for 24 weeks
-3.4mg of terlipressin in 50ml of 10% dextrose over 24 hours delivered in a Surefuser pump via PICC line. This infusion will be changed on a daily basis by hospital in the home nursing staff. Medical reviews will occur weekly for the first 4 weeks then monthly thereafter.
Given all interventions will be administered by nursing staff we will have full knowledge of adherence throughout the study via HITH visits and records
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Cirrhosis with ascites
Exclusion criteria
Alcohol intake within 6 months NHYA heart failure class III or IV intrinsic renal disease eGFR <30 active cancer other than HCC within Milan Terlipressin intolerance
Outcome results
None listed