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Trial registered on ANZCTR
Registration number
ACTRN12624000903583p
Ethics application status
Not yet submitted
Date submitted
21/06/2024
Date registered
24/07/2024
Date last updated
24/07/2024
Date data sharing statement initially provided
24/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Outpatient terlipressin infusion for the prevention of liver events in cirrhosis
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Scientific title
OutPatient continuous Terlipressin Infusion vs huMAn aLbumin for the prevention of decompensation events in adults with cirrhosis - an open label, multi-centre randomised controlled trial
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Secondary ID [1]
312383
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none
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Universal Trial Number (UTN)
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Trial acronym
OPTIMAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cirrhosis
334188
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Condition category
Condition code
Oral and Gastrointestinal
330846
330846
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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
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Intervention code [1]
328885
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Treatment: Drugs
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Comparator / control treatment
Weekly intravenous albumin infusion of 200mL of 20% concentrated albumin for 24 weeks
-this will be administered through a PICC line, similar to the intervention arm, but on a weekly basis as per each institutions local practice (usually in local infusion centre) - this will be administered by infusion centre nurses.
Intervention administered by nursing staff - session attendance will be recorded prospectively
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Control group
Active
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Outcomes
Primary outcome [1]
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Time to major decompensating liver event
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Assessment method [1]
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report initially made by treating physician with each event then adjudicated by an independent outcome committee
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Timepoint [1]
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Time to first decompensating liver event within the 24 week study period will be recorded
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Secondary outcome [1]
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Health care costs
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Assessment method [1]
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Health economist analysis of inpatient and outpatient costs and health utility
relative costs and quality-adjusted life years (QALYs), as well as conducting a budget impact analysis to the hospital sector. Costs for the interventions will be recorded by the research team and hospital events collected from hospital records and Medicare claims data. Costs will be inflated where necessary using the health price index. QALYs will be generated for each patient using the EuroQol-5D 5-level version (EQ-5D-5L) health utility tool
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Timepoint [1]
436663
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All data on hospitalisations will be prospectively collated by site nursing coordinators over the 24 weeks. Economic analysis will occur at end of study
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Secondary outcome [2]
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Total hospitalisation days, cause for hospitalisation (liver events vs non-liver events)
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Assessment method [2]
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clinical records and patient reviews
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Timepoint [2]
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All data on hospitalisations will be prospectively collated by site nursing coordinators over the 24 weeks.
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Secondary outcome [3]
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Quality of life
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Assessment method [3]
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PROMIS-29+2 questionnaire
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Timepoint [3]
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-baseline
-week 4 post-baseline
-week 8 post-baseline
-week 12 post-baseline
-week 24 post-baseline
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Secondary outcome [4]
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Muscle strength
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Assessment method [4]
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Handgrip strength via dynamometer
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Timepoint [4]
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baseline
week 4 post-baseline
week 8 post-baseline
week 12 post-baseline
week 24 post-baseline
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Secondary outcome [5]
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Muscle function
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Assessment method [5]
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liver frailty index
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Timepoint [5]
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baseline
week 4 post-baseline
week 8 post-baseline
week 12 post-baseline
week 24 post-baseline
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Secondary outcome [6]
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Nutrition assessment
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Assessment method [6]
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Subjective Global Assessment
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Timepoint [6]
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Baseline
week 4 post-baseline
week 8 post-baseline
week 12 post-baseline
week 24 post-baseline
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Secondary outcome [7]
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Minimal hepatic encephalopathy
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Assessment method [7]
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Animal naming test
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Timepoint [7]
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Baseline
Week 4 post-baseline
Week 8 post-baseline
Week 12 post-baseline
Week 16 post-baseline
Week 20 post-baseline
Week 24 post-baseline
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Eligibility
Key inclusion criteria
Cirrhosis with ascites
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Powered to assess for a 30% absolute reduction in incidence of hospitalisation for decompensating liver events (estimating 30% in terlipressin arm and 60% in albumin arm)
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
1/06/2027
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
316792
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Address [1]
316792
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Country [1]
316792
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
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Country
Australia
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Secondary sponsor category [1]
319013
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None
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Name [1]
319013
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Address [1]
319013
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Country [1]
319013
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/10/2024
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Approval date [1]
315560
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Ethics approval number [1]
315560
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Summary
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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Marie Sinclair
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Address
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Austin Health, 145 Studley Road, Heidelberg, VIC, Australia 3084
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Country
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Australia
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Phone
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+61394965353
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Marie Sinclair
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Address
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Austin Health, 145 Studley Road, Heidelberg, VIC, Australia 3084
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Country
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Australia
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Phone
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+61394965353
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Marie Sinclair
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Address
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Austin Health, 145 Studley Road, Heidelberg, VIC, Australia 3084
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Country
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Australia
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Phone
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+61394965353
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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