Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001550897
Ethics application status
Approved
Date submitted
1/10/2021
Date registered
15/11/2021
Date last updated
15/11/2021
Date data sharing statement initially provided
15/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute Stress Response to Non-Severe Burn Injuries
Scientific title
Acute Stress Response in Patients with Non-Severe Burn Injuries Scheduled to Undergo Surgery
Secondary ID [1] 305453 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn Injuries 323832 0
Condition category
Condition code
Injuries and Accidents 321338 321338 0 0
Burns

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will examine individuals presenting to the Fiona Stanley Hospital State Adult Burns Unit with less than or equal to 20% body surface area burn injuries, who are expected to undergo at least one surgery during inpatient admission. Participation will involve attendance at face-to-face in both an inpatient and outpatient capacity. Sessions will last approximately 90 minutes, involving a 1 hour follow-up after consumption of a 300ml glucose drink containing 75g of glucose, with observation of respiratory function post-consumption, as well as collection of a blood sample before and after glucose drink consumption, heart rate measurement via a wearable heart rate monitor, assessment of whole body free fat mass using bioimpedance electrodes, assessment of grip strength, and completion of two questionnaires. Each of these components will take approximately 5 minutes to complete. Assessment of energy expenditure using two devices will occur prior to surgery, which will add approximately 30 minutes to the initial session. The assessments will all be completed by a qualified Exercise Physiologist, except for the blood collection that will be drawn by a resident medical officer or phlebotomy accredited researcher.

These observation sessions will occur four times during participation in the study, spanning across a 12-13 month period. These sessions will take place 24-48 hours prior to surgery, 48-72 hours post surgery, 6 weeks post-surgery and 12 months post-surgery.
Intervention code [1] 321852 0
Early Detection / Screening
Intervention code [2] 322041 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329123 0
Metabolic flexibility - determined by changes observed in respiratory exchange ratio (RER) as measured by sampling of expired gas using indirect calorimetry, post-consumption of the standardized high carbohydrate meal in the form of a 300ml glucose drink containing 75g of glucose.
Timepoint [1] 329123 0
RER will be measured for a continuous 60 minute period following the consumption of the standardised high carbohydrate meal at each assessment.

Baseline assessment: ~48 hours pre surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment 12 month post surgery
Secondary outcome [1] 401542 0
Inflammatory markers - Interleukin 2 and 6, tumour necrosis factor alpha (TNF-alpha), C serum reactive protein (CRP) will be assessed from blood samples (plasma serum).
Timepoint [1] 401542 0
Baseline: 48 hours pre surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment: 12 months post surgery
Secondary outcome [2] 401543 0
Heart rate variability assessed using a wearable heart rate monitor (Polar RS10)
Timepoint [2] 401543 0
Baseline: 48 hours pre surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment: 12 months post surgery
Secondary outcome [3] 401544 0
HbA1c - long term measure of glucose control, analysed from a blood sample.
Timepoint [3] 401544 0
Baseline: 48 hours pre surgery
2nd timepoint: 12 months post surgery
Secondary outcome [4] 401545 0
Blood glucose levels pre and post metabolic flexibility assessment (twice per testing session) using a point of care blood glucose monitor that will analyse a blood sample.

The metabolic flexibility assessment will involve the patient completing a 15 minute baseline respiratory assessment from expired gas, followed by the consumption of a 300ml glucose drink, followed by a subsequent 60 minute continuous respiratory analysis where expired gas will be analysed.
Timepoint [4] 401545 0
Blood glucose will be assessed immediately prior to the consumption of the standardised high carbohydrate meal, and will be assessed again 1 hour post-consumption at each assessment.

Baseline: 48 hours pre surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment: 12 months post surgery
Secondary outcome [5] 401546 0
Bio impedance spectroscopy - Whole body fat free mass
Timepoint [5] 401546 0
Baseline: 48 hours pre surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment: 12 months post surgery
Secondary outcome [6] 401547 0
Grip Strength - Quasi measure of whole body strength assessed using a hand-held dynamometer.
Timepoint [6] 401547 0
Baseline: 48 hours pre surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment: 12 months post surgery
Secondary outcome [7] 401549 0
Questionnaires - IPAQ short form assessing physical activity levels
Timepoint [7] 401549 0
Baseline: 48 hours pre surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment: 12 months post surgery
Secondary outcome [8] 401550 0
Energy expenditure - using the COSMED Quark device
Timepoint [8] 401550 0
Baseline: 48 hours pre surgery
Secondary outcome [9] 402286 0
Questionnaire - DASI to assess daily activity status
Timepoint [9] 402286 0
Baseline: 48 hours prior to surgery
2nd assessment: 48-72 hours post surgery
3rd assessment: 6 weeks post surgery
4th assessment: 12 months post surgery
Secondary outcome [10] 402287 0
Energy expenditure - using the eCAL device
Timepoint [10] 402287 0
Baseline: 48 hours pre surgery

Eligibility
Key inclusion criteria
Less than or equal to 20% total body surface area burn injury
Expected to undergo at least one surgery during their inpatient admission for a burn injury
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Facial burns (if unable to form a seal around the mouthpiece for the metabolic assessment)
Patients on continuous naso-gastric feeding

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size for this study was calculated using a priori power analysis and identified 82 paired measures will be needed to observe an effect of 0.39 (from a previous study validating the COSMED Quark device) at a power of 80% and an alpha of 0.05. For the longitudinal aspect of the study, this will allow a significant drop off due, as only 45 participants are required for the analysis of the repeated measures across the 4 time points to determine a small change in RER of 0.15 with a power of 80% and an alpha of 0.05. This significant change in the latent sample size is expected and has been accommodated for in the estimation to account for drop off of the rural patients, which account for up to 50% of inpatient admissions, being unable to attend the 1 year follow up.

For statistical analysis of the data, descriptors of the participants will be preferentially presented as mean and standard deviation. The validation component of the study will be analysed using a Bland Altman plot to determine agreement between the two devices, with student paired t-tests being used for resting energy expenditure. For the repeated measures aspect one way repeated measures ANOVA will be used for the primary and secondary outcomes, with a paired sample t test also being used to determine the difference between pre and post surgery resting energy expenditure. All data analysis will be completed using the latest version of SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2021
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
23/12/2022
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20653 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 35443 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 309809 0
University
Name [1] 309809 0
Murdoch University
Country [1] 309809 0
Australia
Funding source category [2] 309810 0
Charities/Societies/Foundations
Name [2] 309810 0
Fiona Wood Foundation
Country [2] 309810 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, WA, 6150
Country
Australia
Secondary sponsor category [1] 310842 0
Charities/Societies/Foundations
Name [1] 310842 0
Fiona Wood Foundation
Address [1] 310842 0
11 Robin Warren Drive, Murdoch, WA, 6150
Country [1] 310842 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309556 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 309556 0
Ethics committee country [1] 309556 0
Australia
Date submitted for ethics approval [1] 309556 0
12/04/2021
Approval date [1] 309556 0
08/06/2021
Ethics approval number [1] 309556 0
Ethics committee name [2] 309557 0
Human Research Ethics Committee Murdoch University
Ethics committee address [2] 309557 0
Ethics committee country [2] 309557 0
Australia
Date submitted for ethics approval [2] 309557 0
07/09/2021
Approval date [2] 309557 0
21/09/2021
Ethics approval number [2] 309557 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114578 0
Mr Tyler Osborne
Address 114578 0
Fiona Wood Foundation
11 Robin Warren Drive, Murdoch, WA, 6150
Country 114578 0
Australia
Phone 114578 0
+61424206818
Fax 114578 0
Email 114578 0
[email protected]
Contact person for public queries
Name 114579 0
Tyler Osborne
Address 114579 0
Fiona Wood Foundation
11 Robin Warren Drive, Murdoch, WA, 6150
Country 114579 0
Australia
Phone 114579 0
+610861522064
Fax 114579 0
Email 114579 0
[email protected]
Contact person for scientific queries
Name 114580 0
Tyler Osborne
Address 114580 0
Fiona Wood Foundation
11 Robin Warren Drive, Murdoch, WA, 6150
Country 114580 0
Australia
Phone 114580 0
+61424206818
Fax 114580 0
Email 114580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The sharing of the de-identified data, raw, line by line data for each participant outside of the investigator team is yet to be decided pending future projects.


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.