Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000123549
Ethics application status
Approved
Date submitted
22/01/2015
Date registered
11/02/2015
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Gender & Adiposity on Burns Mortality
Scientific title
Effects of adiposity, Body Mass Index and cytokine levels on the outcomes and survival of burn patients with more than 15% burns to the total body surface area
Secondary ID [1] 284984 0
Nil
Universal Trial Number (UTN)
U1111-1159-2965
Trial acronym
EGAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burns 292488 0
Condition category
Condition code
Injuries and Accidents 292799 292799 0 0
Burns

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
duration of inpatient stay
Target follow-up type
Weeks
Description of intervention(s) / exposure
The aims of this study are to (1) evaluate the differences in the inflammatory cytokine response to burn injury between women and men (2) determine if obesity/ adiposity contributes to the inflammatory cytokine response to burn injury.

This trial does not involve a true intervention/ exposure.

This trial will recruit women and men with burn injuries involving at least 15% total body surface area.

A 10ml blood sample is obtained during a routine laboratory blood draw at approximately 72 hours post-injury.

The extent of adiposity among male and female burn patients are measured using body mass index (BMI) and percent body fat calculation. The patient’s weight and height are recorded to calculate the BMI (weight/height2). Skin fold caliper measurements are taken at three points (chest, abdomen and thigh in men; triceps, supra-iliac region and thigh in women) to measure subcutaneous fat thickness (Jackson/Pollock 3 Caliper Method) and converted to a body fat percentage using a freely available online calculator http://www.linear-software.com/online.html.

Participants are observed from the time of their admission until discharge from hospital.
Intervention code [1] 289815 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293598 0
mortality rate
Timepoint [1] 293598 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge or death
Primary outcome [2] 294190 0
adiposity (assessed by body mass index calculations and skin fold caliper measurements)
Timepoint [2] 294190 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge or death
Primary outcome [3] 294191 0
cytokines (assessed via serum assays)
Timepoint [3] 294191 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge or death
Secondary outcome [1] 311433 0
length of hospital stay (assessed via data from patient medical records)
Timepoint [1] 311433 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge from hospital
Secondary outcome [2] 311434 0
length of ICU stay (assessed via data from patient medical records)
Timepoint [2] 311434 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge from hospital
Secondary outcome [3] 311435 0
ventilator days (assessed via data from patient medical records)
Timepoint [3] 311435 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge from hospital
Secondary outcome [4] 311436 0
number of operations (assessed via data from patient medical records)
Timepoint [4] 311436 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge from hospital
Secondary outcome [5] 311437 0
graft loss requiring further surgery (assessed via data from patient medical records)
Timepoint [5] 311437 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge from hospital
Secondary outcome [6] 311438 0
presence of infection/ sepsis (assessed via data from patient medical records)
Timepoint [6] 311438 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge from hospital
Secondary outcome [7] 311439 0
discharge disposition (assessed via data from patient medical records)
Timepoint [7] 311439 0
from admittance to the Victorian Adult Burns Service (The Alfred) until discharge from hospital

Eligibility
Key inclusion criteria
* adult patients (at least 18 years of age)
* burns greater than or equal to 15% total body surface area (TBSA)
* patient admitted to the Victorian Adult Burns Service (The Alfred).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* patients who present (or referred) later than three days after sustaining their injury
* patients with multi-trauma injuries (ie neurosurgical, orthopaedic or general surgical injuries)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Differences in cytokine levels between men and women are compared using bivariate analysis after correcting for differences in age and burn size. Multivariate analyses are performed to assess interactions between sex, burn size, cytokine levels, adiposity, clinical markers of outcome and burns survival.

This is a small pilot cohort study expecting to recruit approximately thirty patients per year. As a small pilot single cohort study, results may or may not reach statistical significance. Outcomes will be compared with published literature.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2015
Actual
2/02/2015
Date of last participant enrolment
Anticipated
1/02/2017
Actual
31/12/2017
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3147 0
The Alfred - Prahran
Recruitment postcode(s) [1] 8925 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 290251 0
Hospital
Name [1] 290251 0
Victorian Adult Burns Service
The Alfred
Country [1] 290251 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd
Melbourne
Victoria 3004
Australia
Country
Australia
Secondary sponsor category [1] 288958 0
None
Name [1] 288958 0
Address [1] 288958 0
Country [1] 288958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292254 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 292254 0
55 Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 292254 0
Australia
Date submitted for ethics approval [1] 292254 0
Approval date [1] 292254 0
26/09/2014
Ethics approval number [1] 292254 0
346/14

Summary
Brief summary
The aims of this study are to (1) evaluate the differences in the inflammatory cytokine response to burn injury between women and men (2) determine if obesity/ adiposity contributes to the inflammatory cytokine response to burn injury.

We hypothesise that (1) a quantifiable difference in inflammatory cytokines exist between women and men with burn injury, and this correlates with clinical markers of outcome (2) obesity/ adiposity influences the inflammatory cytokine response to burn injury, and this correlates with clinical markers of outcome and survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49946 0
Ms Heather Cleland
Address 49946 0
Victorian Adult Burns Service
The Alfred
55 Commercial Road
Melbourne
Victoria 3004
Country 49946 0
Australia
Phone 49946 0
+61(3) 9076 3626
Fax 49946 0
Email 49946 0
h.cleland@alfred.org.au
Contact person for public queries
Name 49947 0
Cheng Hean Lo
Address 49947 0
Victorian Adult Burns Service
The Alfred
55 Commercial Road
Melbourne
Victoria 3004
Country 49947 0
Australia
Phone 49947 0
+61(3) 9076 3626
Fax 49947 0
Email 49947 0
c.lo@alfred.org.au
Contact person for scientific queries
Name 49948 0
Cheng Hean Lo
Address 49948 0
Victorian Adult Burns Service
The Alfred
55 Commercial Road
Melbourne
Victoria 3004
Country 49948 0
Australia
Phone 49948 0
+61(3) 9076 3626
Fax 49948 0
Email 49948 0
c.lo@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
NA


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.