Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000963628p
Ethics application status
Submitted, not yet approved
Date submitted
23/08/2023
Date registered
6/09/2023
Date last updated
6/09/2023
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Flinders Albumin In The Home Project
Scientific title
Flinders Albumin In The Home Project: Assessing the feasibility of administering albumin infusions at home for adults with liver disease
Secondary ID [1] 310451 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FAITH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ascites 331233 0
Decompensated Liver Disease 331234 0
Liver Cirrhosis 331235 0
Refractory ascites 331236 0
Condition category
Condition code
Oral and Gastrointestinal 327994 327994 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves the administration of intravenous human albumin weekly at home rather than in the hospital setting. Each participant will receive an intravenous infusion of 20% Home Albumin in 100mL vials at a dose of 40g twice weekly for the first two weeks, and 40g weekly thereafter for the study duration (six months) administered by South Australian Community Care Nurses.
Intervention code [1] 326848 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335849 0
Number of eligible patients enrolled in the study who received the planned course of human albumin at home. Eligible patient data will be determined by a review of study enrolment logs, administration of albumin data will be determined by a review of the community care nurses infusion records.
Timepoint [1] 335849 0
6 months from start of intervention
Secondary outcome [1] 425885 0
Frequency of admissions for large volume paracentesis as determined by review of medical records
Timepoint [1] 425885 0
6 months from start of intervention
Secondary outcome [2] 425887 0
Any change in renal function as assessed by review of blood results specifically any change in eGFR, Creatinine and Urea levels.
Timepoint [2] 425887 0
6 months from start of intervention
Secondary outcome [3] 425888 0
Any change in serum albumin level
Timepoint [3] 425888 0
6 months from start of intervention
Secondary outcome [4] 425889 0
Any change in readmissions to hospital for liver-related hospitalisations (including admissions for large volume paracentesis) as determined by review of medical records
Timepoint [4] 425889 0
6 months from start of intervention
Secondary outcome [5] 425890 0
Safety by measurement of adverse outcomes due to home human albumin infusion including incidence of infections, fluid overload, and reasons for ceasing human albumin infusions as determined by review of serious adverse events, and community nurse medical records.
Timepoint [5] 425890 0
6 months from start of intervention
Secondary outcome [6] 425891 0
Acceptability using satisfaction survey designed specifically for this study.
Timepoint [6] 425891 0
6 months from time of recruitment
Secondary outcome [7] 425892 0
Treatment cost-effectiveness as measured by cost comparison of at home human albumin compared to in hospital sourced from Finance department of the hospital and the community nursing service used for home visits.
Timepoint [7] 425892 0
6 months from start of intervention
Secondary outcome [8] 426166 0
Change in dose of diuretics tolerated as determined by review of patients medication list
Timepoint [8] 426166 0
6 months from start of intervention

Eligibility
Key inclusion criteria
• Age >18 years with capacity to consent for treatment
• Patient with mild cognitive impairment, at treating doctor and/or PI’s discretion
• Under active management by FMC Hepatology and Transplant Medicine Unit
• Patients with decompensated liver disease (Child Pugh Score B or C) with related symptom of:
• Ascites or hepatic hydrothorax with or without intolerance to diuretics
• HRS or acute kidney injury (AKI)
• Persistent peripheral oedema
• Severe hypoalbuminaemia <25g/L.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients not managed by the FMC Hepatology Unit
• Unsafe environments for conducting home visits
• Patients with a diagnosis of heart failure
• Patients with chronic kidney disease
• Patients with pulmonary hypertension
• Patients who are difficult to cannulate (previously required medical officer assistance or multiple attempts for previous cannulation)
• Patients requiring weekly Large Volume Paracentesis
• Patients with severe hepatic encephalopathy or without cognitive capacity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In view of the small number of study subjects, the data obtained will be described in detail using descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25443 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 41187 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 314658 0
Hospital
Name [1] 314658 0
Flinders Medical Centre
Country [1] 314658 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 316622 0
None
Name [1] 316622 0
Address [1] 316622 0
Country [1] 316622 0
Other collaborator category [1] 282799 0
Other Collaborative groups
Name [1] 282799 0
Metropolitan Referral Unit
Address [1] 282799 0
Department of Health and Wellbeing
11 Hindmarsh Square
Adelaide SA 5000
Country [1] 282799 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313676 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 313676 0
Flinders Medical Centre, Level 6, Ward 6C, Room 6A219
Flinders Drive, Bedford Park, SA 5042
Ethics committee country [1] 313676 0
Australia
Date submitted for ethics approval [1] 313676 0
14/08/2023
Approval date [1] 313676 0
Ethics approval number [1] 313676 0

Summary
Brief summary
We plan to explore the feasibility of providing human albumin infusions in the home setting by community nurses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128978 0
Ms Kylie Bragg
Address 128978 0
C/- Level 3 Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 128978 0
Australia
Phone 128978 0
+61 0466792661
Fax 128978 0
+61 8 82043943
Email 128978 0
kylie.bragg@sa.gov.au
Contact person for public queries
Name 128979 0
Mrs Rachel Wundke
Address 128979 0
C/- Level 3 Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 128979 0
Australia
Phone 128979 0
+61 0466792661
Fax 128979 0
+61 8 82043943
Email 128979 0
rachel.wundke@sa.gov.au
Contact person for scientific queries
Name 128980 0
Ms Kylie Bragg
Address 128980 0
C/- Level 3 Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 128980 0
Australia
Phone 128980 0
+61 0466792661
Fax 128980 0
+61 8 82043943
Email 128980 0
kylie.bragg@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient-specific information is not relevant for public. Averages and counts of patient numbers only will be used.


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.