Trial Review

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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
Sex
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
23/11/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
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
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
[email protected]
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
[email protected]

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.