Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000562673
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
30/09/2005
Date last updated
30/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study to examine the efficacy of terlipressin in the treatment of hepatorenal syndrome.
Scientific title
A non-blinded randomised control study to examine the efficacy of terlipressin compared to standard care in improving renal function in patients with hepatorenal syndrome.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatorenal syndrome 688 0
Condition category
Condition code
Renal and Urogenital 762 762 0 0
Other renal and urogenital disorders
Renal and Urogenital 763 763 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard care + terlipressin for hepatorenal syndrome
Duration of intervention is 5 days.
Intervention code [1] 591 0
None
Comparator / control treatment
Standard care (IV fluids +/- antibiotics if sepsis is suspected)
Control group
Active

Outcomes
Primary outcome [1] 966 0
Primary end point is time from randomisation until serum creatinine has fallen to less than 0.15mmol/L
Timepoint [1] 966 0
Secondary outcome [1] 1834 0
Requirement for haemofiltration/dialysis
Timepoint [1] 1834 0
Secondary outcome [2] 1835 0
Requirement for intensive care(ICU)
Timepoint [2] 1835 0
Secondary outcome [3] 1836 0
Survival during inpatient stay
Timepoint [3] 1836 0
Secondary outcome [4] 1837 0
Days in hospital
Timepoint [4] 1837 0
Secondary outcome [5] 1838 0
Days in ICU
Timepoint [5] 1838 0
Secondary outcome [6] 1839 0
Daily urine output
Timepoint [6] 1839 0
Secondary outcome [7] 1840 0
Change in renal and serumsodium concentration
Timepoint [7] 1840 0
From enrolment until day 5.

Eligibility
Key inclusion criteria
Cirrhotic patients admitted with hepatorenal syndrome (serum creatinine >0.15 with urine sodium <20 mmol).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of other vasoactive drugs, pregnancy, age <18 years, known severe coronary artery disease, AMI within previous 6 months, known intestinal iscchaemia, known severe cerebrovascular disease, CVA within previous 6 months and uncontrolled hypertension.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software performed by pharmacy department
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 843 0
Commercial sector/Industry
Name [1] 843 0
Ferring Pharmaceuticals
Country [1] 843 0
Primary sponsor type
Other
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 710 0
None
Name [1] 710 0
N/A
Address [1] 710 0
Country [1] 710 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36232 0
Address 36232 0
Country 36232 0
Phone 36232 0
Fax 36232 0
Email 36232 0
Contact person for public queries
Name 9780 0
Dr Steve Lontos
Address 9780 0
Department of Gastroenterology
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 9780 0
Australia
Phone 9780 0
+61 3 94965000
Fax 9780 0
+61 3 9496 3487
Email 9780 0
Steve.Lontos@austin.org.au
Contact person for scientific queries
Name 708 0
Dr Paul Gow
Address 708 0
Department of Gastroenterology
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 708 0
Australia
Phone 708 0
+61 3 94965151
Fax 708 0
+61 3 94963487
Email 708 0
Paul.Gow@austin.org.au

No information has been provided regarding IPD availability


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.