Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001816246
Ethics application status
Approved
Date submitted
1/11/2018
Date registered
7/11/2018
Date last updated
21/06/2021
Date data sharing statement initially provided
7/11/2018
Date results information initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An audit of nutrition practices in critically ill trauma patients with or without head injury
Scientific title
An audit of nutrition practices in trauma patients with or without head injury over time
Secondary ID [1] 296493 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 310274 0
Critically ill 310275 0
Head Trauma 310276 0
Condition category
Condition code
Diet and Nutrition 309010 309010 0 0
Other diet and nutrition disorders
Injuries and Accidents 309036 309036 0 0
Other injuries and accidents
Public Health 309037 309037 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 nutritional prescription and delivery practices of critically ill patients admitted to ICU at the RAH will be reviewed. Nutritional data will be collected for patients admitted to ICU during 2005-2006 and 2018-2019.
Intervention code [1] 312813 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307966 0
To evaluate the change in total energy (kcal/day) delivery between two cohorts of critically ill trauma patients admitted to the RAH ICU in 2005 and 2019. Assessed by the dietitian prescription's in medical records as well as ICU charts with actual feed received.
Timepoint [1] 307966 0
For length of ICU stay
Secondary outcome [1] 353517 0
To evaluate differences in calorie prescription between critically ill trauma patients with and without a head injury during 2005 and 2006, and between 2005 and 2019. Assessed by the dietitian prescription's in medical records as well as ICU charts with actual feed received. Actual calories and protein received will be calculated from the specific formula received.
Timepoint [1] 353517 0
For length of ICU stay
Secondary outcome [2] 353518 0
To evaluate differences in calorie delivery between critically ill trauma patients with and without a head injury during 2005 and 2006, and between 2005 and 2019. Assessed by the dietitian prescription's in medical records as well as ICU charts with actual feed received. Actual calories received will be calculated from the specific formula received.
Timepoint [2] 353518 0
For length of ICU stay
Secondary outcome [3] 353519 0
To evaluate differences in protein prescription between critically ill trauma patients with and without a head injury during 2005 and 2006, and between 2005 and 2019. Assessed by the dietitian prescription's in medical records as well as ICU charts with actual feed received. Actual protein received will be calculated from the specific formula received.
Timepoint [3] 353519 0
For length of ICU stay
Secondary outcome [4] 353520 0
To evaluate differences in protein delivery between critically ill trauma patients with and without a head injury during 2005 and 2006, and between 2005 and 2019. Assessed by the dietitian prescription's in medical records as well as ICU charts with actual feed received. Actual protein received will be calculated from the specific formula received.
Timepoint [4] 353520 0
For length of ICU stay

Eligibility
Key inclusion criteria
Cohort 1:
Trauma without head injury
• Admitted to RAH ICU from February 2005 to December 2006
• Aged >=18 years old
• Received enteral nutrition
• No head injury defined as:
I. ICD-10 codes S10-S99 and T00-T98 ICD-10 codes S10-S99 (Injuries to neck, thorax, abdomen, lower back, lumbar spine, pelvis, shoulder, upper arm, elbow and forearm, wrist and hand, hip and thigh, knee and lower leg, ankle and foot) and T00-T98 (multiple body regions, unspecified trunk, limb or body region, effects of foreign body entering through natural orifice, burns and corrosion's, frostbite, poisoning, toxic effects, unspecified from external causes, early complications from trauma, complications of surgery and medical care, sequelae of injuries)
II. Absence of alterations in brain function or pathology

Trauma with head injury
• Admitted to RAH ICU from February 2005 to December 2006
• Aged >=18 years old
• Received enteral nutrition
• Head injury defined as
I. ICD-10 codes S00-S09 (as above)
II. Any alteration in brain function or pathology

Cohort 2:
Trauma without head injury
• Admitted to RAH ICU from September 2018 onwards
• Aged >=18 years old
• Receiving enteral nutrition
• No head injury defined as:
I. ICD-10 codes S10-S99 and T00-T98 (as above)
II. Absence of alterations in brain function or pathology

Trauma with head injury
• Admitted to RAH ICU from September 2018 onwards
• Aged >=18 years old
• Receiving enteral nutrition
• Head injury defined as
I. ICD-10 codes S00-S09 (as above)
II. Any alteration in brain function or pathology
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not applicable

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
This is an exploratory practice audit and hence no power calculation was conducted. Cohort 1 includes 127 patients for which data was collected in a prospective manner as part of a clinical audit over an 18 month time-period from February 2005. Cohort 2 will include prospectively collected patient data from 2018 onwards to match cohort 1, hence including 127 patients.

Continuous variables will be summarised with mean and standard deviation, or median and interquartile range, as appropriate. Categorical variables will be presented as n (%). Patient demographics will be compared between cohorts using t-tests or Mann-Whitney tests for continuous variables, and chi-square or Fishers Exact Test for categorical variables. The primary outcome of mean total delivered calories (kcal/day) will be compared between the two cohorts using an independent samples t-test for an unadjusted analysis, and in a multiple linear regression including cohort and baseline characteristics (age, sex, APACHE-II score at ICU admission) to control for any differences in patient demographics over time. Secondary energy and protein outcomes will be analysed for differences between cohorts and patients with and without head injuries via a linear model with fixed effects for cohort and head injury (Y/N) and tested with planned contrasts. Statistical significance will be assessed at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/11/2018
Actual
13/12/2018
Date of last participant enrolment
Anticipated
30/11/2020
Actual
21/09/2020
Date of last data collection
Anticipated
Actual
30/09/2020
Sample size
Target
254
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12323 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 24561 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301080 0
Hospital
Name [1] 301080 0
Intensive Care Unit Research Department Royal Adelaide Hospital
Country [1] 301080 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital, Port Road, South Australia, Adelaide, 5000
Country
Australia
Secondary sponsor category [1] 300690 0
None
Name [1] 300690 0
Address [1] 300690 0
Country [1] 300690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301833 0
Central Adelaide Local Health Network HREC EC00192
Ethics committee address [1] 301833 0
Ground Floor, Basil Hetzel Institute for Translational Research
28 Woodville Road, Woodville SA
Australia 5000
Ethics committee country [1] 301833 0
Australia
Date submitted for ethics approval [1] 301833 0
29/10/2018
Approval date [1] 301833 0
11/10/2018
Ethics approval number [1] 301833 0

Summary
Brief summary
Enteral nutrition (EN), delivered via a tube into the stomach, provided to critically ill patients is largely inadequate, resulting in muscle wasting and reduced physical function in the long-term. Numerous factors are known to influence nutrition delivery in the intensive care unit (ICU) such as interruptions for procedures, delayed initiation of feeding regimes, under or over prescription, and feed intolerance due to delayed gastric emptying. Further, recent evidence raises doubt as to the benefit of early vs delayed initiation of enteral nutrition and the delivery of calories to full prescribed target early in critical illness. Therefore, an exploration of whether there has been a change in nutrition delivery over time to reflect recommendations, and whether potential barriers to nutrition adequacy are as prevalent now as in the past, is required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88262 0
Mr Luke Weinel
Address 88262 0
Royal Adelaide Hospital, Port Road, South Australia, Adelaide, 5000
Country 88262 0
Australia
Phone 88262 0
+61 439 848 000
Fax 88262 0
Email 88262 0
luke.weinel@sa.gov.au
Contact person for public queries
Name 88263 0
Matthew Summers
Address 88263 0
Royal Adelaide Hospital, Port Road, South Australia, Adelaide, 5000
Country 88263 0
Australia
Phone 88263 0
+61 8 707 41765
Fax 88263 0
Email 88263 0
matthew.summers@sa.gov.au
Contact person for scientific queries
Name 88264 0
Lee-anne Chapple
Address 88264 0
Royal Adelaide Hospital, Port Road, South Australia, Adelaide, 5000
Country 88264 0
Australia
Phone 88264 0
+61 8 707 41763
Fax 88264 0
Email 88264 0
lee-anne.chapple@adelaide.edu.au

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 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.