Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000201572
Ethics application status
Approved
Date submitted
28/01/2024
Date registered
29/02/2024
Date last updated
29/02/2024
Date data sharing statement initially provided
29/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition practices in long-stay critically ill patients
Scientific title
Nutrition practices in long-stay critically ill patients
Secondary ID [1] 311385 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 332658 0
Condition category
Condition code
Diet and Nutrition 329363 329363 0 0
Other diet and nutrition disorders
Public Health 329612 329612 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
The exposure observed is nutritional intake. Nutrition data will be collected daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or ICU discharge. All data is collected based on routine clinical practice, such that participants will receive nutrition intake regardless of their involvement in the study. Data will predominantly be collected from electronic medical records that is collected routinely in clinical practice. However if a patient is orally fed, a 24-hour recall of their food intake. and nutrition symptoms will be collected directly from the patient.. At 90 days post study inclusion, the participant or next of kin will be contacted to obtain data on route of nutrition, nutrition intake from the previous 24 hours, presence of nutrition problems that impact nutrition intake or delivery, and an EQ-5D-5L health-related quality of life questionnaire.
Intervention code [1] 327828 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337180 0
Energy delivery
Timepoint [1] 337180 0
Daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or intensive care unit (ICU) discharge.
Primary outcome [2] 337197 0
Protein delivery
Timepoint [2] 337197 0
Daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or ICU discharge.
Secondary outcome [1] 430985 0
Energy adequacy
Timepoint [1] 430985 0
Daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or ICU discharge.
Secondary outcome [2] 430987 0
Route of feeding
Timepoint [2] 430987 0
Daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or ICU discharge.
Secondary outcome [3] 430988 0
Barriers to nutrition delivery
Timepoint [3] 430988 0
Daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or ICU discharge.
Secondary outcome [4] 430989 0
Dietetic service delivery
Timepoint [4] 430989 0
Daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or ICU discharge.
Secondary outcome [5] 430991 0
Health-related quality of life
Timepoint [5] 430991 0
Day 90 post-study follow-up.
Secondary outcome [6] 431064 0
Protein adequacy
Timepoint [6] 431064 0
Daily for the first 14 days, and then every seven days thereafter (day 21, day 28), censored at day 28, death, or ICU discharge.

Eligibility
Key inclusion criteria
1. Are admitted to the Royal Adelaide Hospital (RAH) ICU;
2. Are aged greater than or equal to 18 years;
3. Have an ICU length of stay of at least 5 days at time of screening and are anticipated to have a total ICU length of stay of at least 7 days as per the treating medical team.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Readmitted to ICU within the current index hospital admission
2. Unable to obtain informed consent (no next of kin (NOK)/NOK unavailable/uncontactable).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Given this is an exploratory descriptive study on nutrition practice, no power calculation will be conducted, with all eligible patients included.

Categorical data will be presented as counts (n) and percentages (%), and continuous data will be reported as mean ± standard deviation (SD) for normally distributed data or median [interquartile range (IQR)] for non-normally distributed data as appropriate. No adjustments will be made for partial days of feeding that occur on ICU admission or ICU discharge days.

Paired samples t-tests will be conducted to assess differences between days 1-7 and 8-14 in the sub-group analysis. A two-sided P-value of less than 0.05 will be considered statistically significant. No corrections for multiple comparisons will be made.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/02/2024
Date of last participant enrolment
Anticipated
21/08/2024
Actual
Date of last data collection
Anticipated
21/11/2024
Actual
Sample size
Target
200
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26072 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 41926 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 315644 0
Hospital
Name [1] 315644 0
RAH Research Committee - Allied Health, Nursing, and Pharmacy Grant
Country [1] 315644 0
Australia
Primary sponsor type
Hospital
Name
Central Adelaide Local Health Network
Address
1 Port Road, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 317746 0
None
Name [1] 317746 0
Address [1] 317746 0
Country [1] 317746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314529 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 314529 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 314529 0
Australia
Date submitted for ethics approval [1] 314529 0
20/12/2023
Approval date [1] 314529 0
25/01/2024
Ethics approval number [1] 314529 0
18800

Summary
Brief summary
Trials of calorie and protein delivery in critically ill patients have failed to show positive outcomes. However, these trials predominately intervene during the acute phase (first 7 days) of an Intensive Care Unit (ICU) admission only, where metabolic responses to critical illness are likely to impair nutrient utilisation. Furthermore, there is an increasing recognition that nutrition is not a short-term intervention, and extended nutrient provision is required to demonstrate benefit. Little is currently known about nutrition practices in patients that have a longer (>7 day) ICU stay. The purpose of the study is to describe nutrition practices in long-stay critically ill adult patients. 200 patients will be recruited at the Royal Adelaide Hospital. Data for all eligible patients will be extracted from the Australian New Zealand Intensive Care Society Adult Patient Database (ANZICS APD) where applicable, and additional data collected from the patient electronic medical record (EMR), bedside nursing staff, or the patient themselves. Data analysis will be conducted in SPSS Statistics software in consultation with qualified biostatistician Ms Kylie Lange from the National Health and medical Research Council (NHMRC) Centre for Research Excellence at The University of Adelaide. This prospective observational study is an integral step in defining key gaps in nutrition delivery to inform a program of research on improving patient recovery through optimal nutrition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131902 0
Ms Cait Davis
Address 131902 0
Royal Adelaide Hospital, 1 Port Road, Adelaide SA 5000
Country 131902 0
Australia
Phone 131902 0
+61 8 7074 1763
Fax 131902 0
Email 131902 0
caitlin.davis2@sa.gov.au
Contact person for public queries
Name 131903 0
A/Prof Lee-anne Chapple
Address 131903 0
Royal Adelaide Hospital, 1 Port Road, Adelaide SA 5000
Country 131903 0
Australia
Phone 131903 0
+61 8 7074 1763
Fax 131903 0
Email 131903 0
lee-anne.chapple@sa.gov.au
Contact person for scientific queries
Name 131904 0
A/Prof Lee-anne Chapple
Address 131904 0
Royal Adelaide Hospital, 1 Port Road, Adelaide SA 5000
Country 131904 0
Australia
Phone 131904 0
+61 8 7074 1763
Fax 131904 0
Email 131904 0
lee-anne.chapple@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This observational study will provide data on energy and protein delivery practices in Australian and New Zealand intensive care units for the sole purpose of advising further study designs on nutrition practices and clinical outcomes. Hence, the data will not be provided publicly.


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.