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Trial registered on ANZCTR
Registration number
ACTRN12623000589684
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
30/05/2023
Date last updated
30/05/2023
Date data sharing statement initially provided
30/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
How much thiamine is enough in malnourished patients receiving total parenteral nutrition?
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Scientific title
Thiamine levels and duration of replacement in patients receiving total parenteral nutrition (TPN) with moderate to severe risk of refeeding - a prospective randomised controlled trial
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Secondary ID [1]
309577
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None
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Universal Trial Number (UTN)
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Trial acronym
TIE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malnutrition
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Total parenteral nutrition
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Thiamine deficiency
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Condition category
Condition code
Diet and Nutrition
326786
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Thiamine replacement (b dose forte brand) 250mg daily intravenously for 7 days
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Intervention code [1]
326005
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Treatment: Drugs
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Comparator / control treatment
Comparator group will be 3 days replacement of thiamine (250mg b dose forte intravenously)
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Control group
Active
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Outcomes
Primary outcome [1]
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Thiamine blood levels (whole blood thiamine - thiamine diphosphate (TDP)
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Assessment method [1]
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Timepoint [1]
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At day 3 and 7 post enrolment
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Secondary outcome [1]
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Economic evaluation comparing cost of two approaches (3 and 7 days) incorporating administration/nursing time, as well as drug costs.
Cost and time data will be sourced from trial hospital pharmacy, and time will be estimated by observing nursing staff administering the medication.
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Assessment method [1]
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Timepoint [1]
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Day 7 following enrolment
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Eligibility
Key inclusion criteria
Receiving total parenteral nutrition
Ability to consent to participate or surrogate decision maker available
Refeeding risk classified as moderate or severe as per 2020 American Society of Parenteral and Enteral Nutrition (ASPEN) refeeding syndrome guideline.
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Minimum age
18
Years
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Maximum age
No limit
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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
Not at risk of re-feeding
Unable to consent.
Duration of TPN expected to be less than 7 days.
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Study design
Purpose of the study
Treatment
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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)
Central computer generated randomisation
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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
Other
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Other design features
Crossover is possible, if thiamine levels are low at day 3, to crossover to 7 days of replenishment.
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Phase
Phase 2 / Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive summaries of patient demographic data will consist of frequency distributions for categorical variables and means (SD) or medians (IQR) for continuous variables. Univariate comparisons between groups will be done using Chi-squared or Fisher Exact tests for categorical data and t-tests or Mann-Whitney U tests for continuous data. Proportions of non-deficiency will be compared between groups at baseline and days 3 and 7 using Chi-squared tests and Generalised linear mixed models (GLMM). Results will be summarised using odds ratios and 95% confidence intervals. LMM with random subject effects will be used to compare raw thiamine levels between groups at baseline and days 3 and 7. Results will be summarised using estimated means and 95% confidence intervals. Cost differences between groups will be described using means (SD) and compared using t tests.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/05/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
65
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
40275
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Charlies Foundation for Research
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Address [1]
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Hospital Avenue Nedlands 6009, WA
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Sir Charles Gairdner Hospital
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Address
Hospital Avenue
Nedlands 6009 WA
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
315592
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Country [1]
315592
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sir Charles Gairdner and Osborne Park Hospital Ethics Committee
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Ethics committee address [1]
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Hospital Avenue
Nedlands WA 6009
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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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Approval date [1]
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30/09/2020
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Ethics approval number [1]
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03911
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Summary
Brief summary
Thiamine deficiency manifests as two conditions: cardiac (wet) beriberi, or Wernicke’s encephalopathy. Furthermore, it can potentiate lactic acidosis through failure of pyruvate to enter the Kreb’s cycle.
Patients who are malnourished are at risk of thiamine deficiency, and traditionally, replacement is given for patients at risk (patients on TPN without micronutrients, those with history of alcohol abuse, starvation states). Thiamine levels are not routinely checked in usual practice, but instead, supplementation is provided based on risk.
The current guidelines give different recommendations (excluding for treatment of beriberi/Wernicke’s, in which the dose is 200-500mg intravenously three times a day for 5-7 days followed by 100mg for 1-2 weeks)
1. For those at high risk of thiamine deficiency, therapeutic guidelines suggests giving 300mg intravenously for 3 days and then 100mg daily for 1-2 weeks
2. In re-feeding syndrome 100mg intravenously for 7-10 days
Clinical Question
Is 3 days of intravenous thiamine replacement in patients receiving TPN AND at risk of refeeding syndrome, sufficient to restore and maintain thiamine levels when measured at day 7?
Hypothesis
In patients at risk of refeeding syndrome, thiamine levels are sufficiently restored with 3 days, as opposed to 7 days, of supplementation.
Methodology
Patients randomized to receive 3 days of intravenous thiamine or 7 days of intravenous thiamine.
Standard dose will be given, 250mg b dose forte intravenous.
Thiamine levels will be measured at day 0, 3 and 7 to ensure adequate blood levels are reached.
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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 Matthew Anstey
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Address
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Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009, WA
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Country
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Australia
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Phone
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+61 8 64571010
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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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A/Prof Matthew Anstey
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Address
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Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009, WA
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Country
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Australia
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Phone
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+61 8 64571010
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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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A/Prof Matthew Anstey
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Address
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Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009, WA
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Country
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Australia
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Phone
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+61 8 64571010
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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)?
Yes
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What data in particular will be shared?
Data dictionaries can be shared.
De-identified patient level data
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When will data be available (start and end dates)?
At the completion of the trial. Available for 5 years after publication.
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Available to whom?
Researchers on reasonable request.
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Available for what types of analyses?
Meta-analyses
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How or where can data be obtained?
On reasonable request to the PI via email (
[email protected]
) . Will need to obtain ethics approval as well for any data sharing
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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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