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Trial registered on ANZCTR


Registration number
ACTRN12605000449639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immunonutritional therapy in liver transplant patients - a randomised trial
Scientific title
A randomised, double-blind trial to investigate effects of an immunonutritional supplement (Impact) versus an isonitrogenous, isocaloric control provided pre- and postoperatively to patients undergoing liver transplantation on pre-transplant nutritional status and post-transplant recovery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage liver disease 564 0
Condition category
Condition code
Other 639 639 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-centre, randomised, double-blind, study comparing nutritional supplementation with Impact (Novartis).
Intervention code [1] 580 0
None
Comparator / control treatment
Isonitrogenous, isocaloric control supplement provided preoperatively to patients on waiting list for liver transplantation and post-transplant for 5 days.
Control group
Active

Outcomes
Primary outcome [1] 750 0
Change in total body protein, measured by neutron activation analysis, over the preoperative period of supplementation.
Timepoint [1] 750 0
Study entry to transplant
Secondary outcome [1] 1534 0
Physiologic function over the preoperative period.
Timepoint [1] 1534 0
Study entry to transplant
Secondary outcome [2] 1535 0
Total body protein and physiologic function
Timepoint [2] 1535 0
Measured at 10, 30, 90, 180 and 360 days post-transplant.
Secondary outcome [3] 1536 0
Health-related quality of life
Timepoint [3] 1536 0
Measured at baseline and 6 and 12 months post-transplant.
Secondary outcome [4] 1537 0
Infectious complications
Timepoint [4] 1537 0
Within first 30 postoperative days.
Secondary outcome [5] 1538 0
Immune status
Timepoint [5] 1538 0
Measured at baseline and day of transplant
Secondary outcome [6] 1539 0
Inflammatory markers and GH/IGF axis
Timepoint [6] 1539 0
At baseline, immediately pre-transplant, and on day 10 post-transplant.

Eligibility
Key inclusion criteria
Listed for elective liver transplantation; written informed consent.
Minimum age
16 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Re-transplant, acute liver failure, pregnancy.

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 envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated variable blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 223 0
New Zealand
State/province [1] 223 0

Funding & Sponsors
Funding source category [1] 700 0
Government body
Name [1] 700 0
Health Research Council of New Zealand
Address [1] 700 0
P.O. Box 5541, Wellesley Street, Auckland
Country [1] 700 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lindsay Plank
Address
Department of Surgery, University of Auckland, P.B. 92019, Auckland
Country
New Zealand
Secondary sponsor category [1] 585 0
None
Name [1] 585 0
Nil
Address [1] 585 0
Country [1] 585 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35725 0
Address 35725 0
Country 35725 0
Phone 35725 0
Fax 35725 0
Email 35725 0
Contact person for public queries
Name 9769 0
Dr Lindsay Plank
Address 9769 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland
Country 9769 0
New Zealand
Phone 9769 0
+64 9 3074935
Fax 9769 0
+64 9 3779656
Email 9769 0
l.plank@auckland.ac.nz
Contact person for scientific queries
Name 697 0
Dr Lindsay Plank
Address 697 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland
Country 697 0
New Zealand
Phone 697 0
+64 9 3074935
Fax 697 0
+64 9 3779656
Email 697 0
l.plank@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results