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Trial registered on ANZCTR


Registration number
ACTRN12620001044910
Ethics application status
Approved
Date submitted
16/08/2020
Date registered
15/10/2020
Date last updated
15/10/2020
Date data sharing statement initially provided
15/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Micronutrient intake from enteral nutrition in critically ill adult patients
Scientific title
Micronutrient INTake from Enteral nutrition in critically ill adult patients expressed as a percentage of the Australia and New Zealand Nutrient Reference Values: a retrospective observational study (The MINT-E Study)
Secondary ID [1] 301985 0
None
Universal Trial Number (UTN)
Trial acronym
The MINT-E Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 318544 0
Condition category
Condition code
Diet and Nutrition 316552 316552 0 0
Other diet and nutrition disorders
Public Health 317343 317343 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Enteral nutrition (EN) is the most preferred and common mode of nutrition provision in mechanically ventilated critically ill patients. Feeding formulas used for EN aim to provide complete nutrition in the form of both macro- and micronutrients. In Australia, the micronutrient composition of EN formulas is guided by standards established for a healthy population by the National Health and Medical Research Council (NHMRC). These standards, termed Nutrient Reference Values (NRVs), include the recommended dietary intake (RDI), adequate intake (AI) and upper level of intake (UL). Limited information is available on the micronutrient intake of critically ill patients receiving EN during routine clinical practice in the Intensive Care Unit (ICU). The aim of this retrospective observational study is to determine daily micronutrient intake of vitamins B12, D, C, A, iron, folate, thiamine, zinc, and selenium delivered from EN to critically ill adults admitted to Box Hill Hospital Intensive Care Unit (ICU), Melbourne, Australia between January 2018 and January 2020. Micronutrient intake will be assessed daily for the first seven days of ICU admission and compared to NRVs. There will be no participant involvement, only access to patient medical records.
Intervention code [1] 318271 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324679 0
Composite outcome - Intake of vitamins B12, D, C, A, iron, folate, thiamine, zinc, and selenium delivered from enteral nutrition (EN) during routine clinical practice in critically ill adult patients expressed as a percentage of the recommended daily intake (RDI) (or adequate intake (AI) where RDI is not reported). Calculation will be completed using the information collected from the patient's electronic medical records.
Timepoint [1] 324679 0
Assessed daily for the first seven days of Intensive Care Unit (ICU) admission
Secondary outcome [1] 385388 0
Composite outcome - Intake of vitamins D, C, A, iron, folate, zinc, and selenium delivered from EN during routine clinical practice in critically ill adult patients expressed as a percentage of the upper level of intake (UL). Calculation will be completed using the information collected from the patient's electronic medical records.
Timepoint [1] 385388 0
Assessed daily for the first seven days of Intensive Care Unit (ICU) admission

Eligibility
Key inclusion criteria
Inclusion criteria
• Admitted to Box Hill Hospital ICU
• Aged 18 years or older
• Mechanically ventilated for at least the first 48 hours of ICU admission
• Prescribed EN in the first 48 hours of ICU admission
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• Patients who received supplemental oral intake at the same time as EN at ICU admission or within the first 48 hours
• Patients who received parenteral nutrition (PN) support at the same time as EN at the start of ICU admission or within the first 48 hours
• Patients who are admitted for palliative care and/or organ donation, are made palliative or die within the first 7 days of ICU admission

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Data analysis will be descriptive, using mean and standard deviation (SD) for normally distributed data and median and interquartile range (IQR) for skewed data. Percentages will be reported as numbers (%). Comparisons of proportions will be made using chi-squared tests for equal proportions and continuous variables using the Independent Samples t-Test or the Wilcoxon Rank Sum Test. A p-value < 0.05 will be considered statistically significant. Analyses will be performed using Stata Statistical Software: Release 14. College Station, TX: StataCorp LP by a Statistician. Subgroups defined apriori are proposed where there are 10 or more patients in each arm.

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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17213 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 30922 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 306959 0
University
Name [1] 306959 0
Monash University
Address [1] 306959 0
Monash University
Melbourne, Victoria 3800
Australia
Country [1] 306959 0
Australia
Primary sponsor type
Individual
Name
Dr Emma Ridley
Address
Australia and New Zealand Intensive Care Research Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 306958 0
None
Name [1] 306958 0
Address [1] 306958 0
Country [1] 306958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306604 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 306604 0
5 Arnold Street
Box Hill
Victoria 3128
Ethics committee country [1] 306604 0
Australia
Date submitted for ethics approval [1] 306604 0
11/05/2020
Approval date [1] 306604 0
23/06/2020
Ethics approval number [1] 306604 0
LR20-042
Ethics committee name [2] 306657 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 306657 0
School of Public Health and Preventive Medicine
Monash University
Level 1, 553 St Kilda Road,
Victoria, Melbourne 3004
Ethics committee country [2] 306657 0
Australia
Date submitted for ethics approval [2] 306657 0
21/07/2020
Approval date [2] 306657 0
22/07/2020
Ethics approval number [2] 306657 0
25379

Summary
Brief summary
When people are critically ill and require treatment in an Intensive Care Unit, they are often unable to eat food. In this situation the standard treatment is to supply them with food dripped into their stomach or bowel through a feeding tube (termed enteral nutrition). Enteral nutrition provides both macronutrients (carbohydrates, protein and fat) and micronutrients (vitamins, minerals and trace elements). In Australia, enteral nutrition formula composition is guided by the National Health and Medical Research Council (NHMRC). These standards, termed Nutrient Reference Values (NRVs), include the recommended dietary intake (RDI), adequate intake (AI) and upper level of intake (UL). However, there is very little information on the amount of micronutrients delivered to critically ill patients during Intensive Care Unit admission. We are conducting a retrospective observational study to assist in determining the micronutrient intake of vitamins B12, D, C, A, iron, folate, thiamine, zinc, and selenium delivered from enteral nutrition to critically ill adults admitted to Box Hill Hospital Intensive Care Unit (ICU), Melbourne, Australia between January 2018 and January 2020. Micronutrient intake will be assessed for the first seven days of ICU admission and compared to Australian NRVs.
Trial website
Trial related presentations / publications
Public notes
This project is being conducted as part of a Masters project through Monash University with Dr Emma Ridley as the primary supervisor.

Contacts
Principal investigator
Name 104434 0
Dr Emma Ridley
Address 104434 0
Australia and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 104434 0
Australia
Phone 104434 0
+61 3 9903 0350
Fax 104434 0
Email 104434 0
emma.ridley@monash.edu
Contact person for public queries
Name 104435 0
Dr Emma Ridley
Address 104435 0
Australia and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 104435 0
Australia
Phone 104435 0
+61 3 9903 0350
Fax 104435 0
Email 104435 0
emma.ridley@monash.edu
Contact person for scientific queries
Name 104436 0
Dr Emma Ridley
Address 104436 0
Australia and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 104436 0
Australia
Phone 104436 0
+61 3 9903 0350
Fax 104436 0
Email 104436 0
emma.ridley@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available via publication or on request in line with the approved ethics application to protect patient anonymity.
What supporting documents are/will be available?
No other documents available
Summary results
No Results