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Trial registered on ANZCTR


Registration number
ACTRN12620001025921p
Ethics application status
Submitted, not yet approved
Date submitted
13/08/2020
Date registered
9/10/2020
Date last updated
9/10/2020
Date data sharing statement initially provided
9/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
NUTRIENT - Nutrition practice in critically ill adults - an observational study
Scientific title
Nutrition practice in critically ill adults - an observational study
Secondary ID [1] 301914 0
NIl
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition in critically ill adults 318428 0
Condition category
Condition code
Diet and Nutrition 316434 316434 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observational study of nutrition practices in critically ill adults across Australia and New Zealand.
In a 7 day study period, all adult ICU and HDU patients who are admitted to ICU for 48 hours or more and do not meet any of the exclusion criteria will be included. Data collection will commence and continue until hospital discharge, day 28 or if the patient is deceased (whichever occurs first). Observational data will be collected days 1 to 7 of their ICU stay (whilst present in ICU) and then days 7 (if on the ward), 14, 21 and 28 (whether they are in ICU or the ward).
Patient data to be collected is baseline admission data and demographics, initial ICU nutrition assessment data, daily nutrition data in ICU for 7 days then weekly to day 28, ward nutrition data from date of transfer from ICU to hospital discharge (up to day 28), functional oral intake scale and outcome data (nutrition at d/c, hosp and ICU lenth of stay and discharge location).

From date of enrolment all data will be prospective, admission/baseline data will be retrospective.
Intervention code [1] 318320 0
Not applicable
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324736 0
Energy prescription
Quantification of nutrition intake, data captured from medical records
Timepoint [1] 324736 0
Daily data collection in ICU for days 1 to 7 and then weekly until day 28. If patient is transferred to the ward data collection in weekly ie 7, 14, 21,28
Primary outcome [2] 324737 0
Feeding intolerances
Assessed from patient medical records
Timepoint [2] 324737 0
Daily data collection in ICU for days 1 to 7 and then weekly until day 28. If patient is transferred to the ward data collection in weekly ie 7, 14, 21,28
Primary outcome [3] 324738 0
Delivery of dietetic service
Patient records and case report form being completed by dietetic department
Timepoint [3] 324738 0
Daily data collection in ICU for days 1 to 7 and then weekly until day 28. If patient is transferred to the ward data collection in weekly ie 7, 14, 21,28
Secondary outcome [1] 385608 0
Descriptions in nutrition practice variability across Australia and New Zealand
Patient data collected from medial records and then grouped during analysis
Timepoint [1] 385608 0
Daily data collection in ICU for days 1 to 7 and then weekly until day 28. If patient is transferred to the ward data collection in weekly ie 7, 14, 21, 28
Secondary outcome [2] 386812 0
Hospital length of stay
Collected from patient medical records
Timepoint [2] 386812 0
Admission and discharge date to hospital
Secondary outcome [3] 386813 0
Infectious complications
Pt +ve blood or serum cultures documented in medical records
Timepoint [3] 386813 0
Daily data collection in ICU for days 1 to 7 and then weekly until day 28. If patient is transferred to the ward data collection in weekly ie 7, 14, 21,28
Secondary outcome [4] 387637 0
Protein prescription (primary outcome)
Quantification of nutrition intake, data captured from medical records
Timepoint [4] 387637 0
Daily data collection in ICU for days 1 to 7 and then weekly until day 28. If patient is transferred to the ward data collection in weekly ie 7, 14, 21,28

Eligibility
Key inclusion criteria
1. Age 18 years or older
2. Admitted to ICU after 00:00 on the date of study commencement
3. Remain in ICU for greater than 48 hours
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have been deemed ready to be discharged by the treating team within 48 hours of ICU admission but have not been able to be discharged within 48 hours of ICU admission for logistical reasons (e.g. due to bed unavailability, inability to return home)
2. Patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of ICU admission

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
This study will quantify nutrition intake, resourcing, and clinical outcomes in critically ill patients.
All data will be assessed for normality. Group comparisons will be performed using chi-square tests for equal proportion, student t-tests for normally distributed data and Wilcoxon rank sum tests otherwise, with results presented as counts (%), means (standard deviations) and medians (interquartile range) respectively. Where applicable, longitudinal analysis will be performed using hierarchical mixed modelling with patients nested within sites and both patients and sites treated as random effects. As sample size will be dependent upon the number of admitted patients meeting inclusion criteria, no formal sample size calculations will be performed. All analysis will be conducted using SAS version 9.4 and a two sided p-value of 0.05 will be used to indicate statistical significance.

Recruitment
Recruitment status
Not yet 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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22826 0
New Zealand
State/province [1] 22826 0

Funding & Sponsors
Funding source category [1] 306328 0
Government body
Name [1] 306328 0
Research portion of the Chief Investigators NHMRC emerging fellowship grant
Address [1] 306328 0
National Health and Medical Research Council
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 306328 0
Australia
Funding source category [2] 306443 0
Commercial sector/Industry
Name [2] 306443 0
Nutricia Australia Pty Ltd
Address [2] 306443 0
Level 4, Building D, 12-24 Talavera Rd,
Macquarie Park, NSW 2113
Country [2] 306443 0
Australia
Funding source category [3] 306444 0
Commercial sector/Industry
Name [3] 306444 0
Fresenius Kabi Australia Pty Ltd
Address [3] 306444 0
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Country [3] 306444 0
Australia
Primary sponsor type
University
Name
Monash University
Address
The Australian and New Zealand Intensive Care Research Centre
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria, 3004
Country
Australia
Secondary sponsor category [1] 306960 0
None
Name [1] 306960 0
Address [1] 306960 0
Country [1] 306960 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306539 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 306539 0
55 Commercial Rd,
Melbourne VIC, 3004
Ethics committee country [1] 306539 0
Australia
Date submitted for ethics approval [1] 306539 0
01/09/2020
Approval date [1] 306539 0
Ethics approval number [1] 306539 0

Summary
Brief summary
The aim of the study is to assess nutrition provision and practice over the duration of hospitalisation in critically ill adults in Australia and New Zealand (ANZ) to inform nutrition practice and future reserach. SItes will also use this study as a quality procedure being able to review their individual data compare to other sites in Australia and New Zealand.
All data collected is observational.
Participating sites will enrol eligible patients into the study over a 1 week study period and collect observational nutrition and hospital care data during their ICU admission and ward stay up to day 28, discharge or death (whichever comes first). Data will be collected daily for the first 7 days while the patient remians in ICU and then weekly where on the ward or still in ICU.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104214 0
Dr Emma Ridley
Address 104214 0
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
Country 104214 0
Australia
Phone 104214 0
+61 3 99030350
Fax 104214 0
Email 104214 0
emma.ridley@monash.edu
Contact person for public queries
Name 104215 0
Ms Victoria King
Address 104215 0
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
Country 104215 0
Australia
Phone 104215 0
+61 3 99056646
Fax 104215 0
Email 104215 0
victoria.king@monash.edu
Contact person for scientific queries
Name 104216 0
Ms Victoria King
Address 104216 0
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
Country 104216 0
Australia
Phone 104216 0
+61 3 99056646
Fax 104216 0
Email 104216 0
victoria.king@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
What supporting documents are/will be available?
No other documents available
Summary results
No Results