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Trial registered on ANZCTR


Registration number
ACTRN12619000403134
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
13/03/2019
Date last updated
27/09/2023
Date data sharing statement initially provided
13/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study of critically ill patients with severe acute respiratory distress syndrome.
Scientific title
An observational study of critically ill patients with severe acute respiratory distress syndrome in Australia and New Zealand to determine mortality.
Secondary ID [1] 297616 0
None
Universal Trial Number (UTN)
U1111-1229-5956
Trial acronym
SAGE-ANZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory distress syndrome 311889 0
Condition category
Condition code
Respiratory 310477 310477 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
28
Target follow-up type
Days
Description of intervention(s) / exposure
Acute respiratory distress syndrome (ARDS) is an acute inflammatory lung injury associated with increased pulmonary vascular permeability, loss of aerated lung tissue, impaired gas exchange and requirement for escalation of respiratory support therapy. Patients may ultimately require intubation and institution of mechanical ventilation. ARDS is associated with significant morbidity, mortality and associated ICU costs.
Despite advances in the understanding and recognition of the disease and novel therapies being developed and employed, mortality rates remain high at 40-50%.
We plan to prospectively assess the management of moderate-severe ARDS in intensive care units in Australia and New Zealand.
We will:
• Describe management practices and variation in use of ventilator strategies and adjunctive therapies
• Determine factors associated with survival or need for adjunctive therapy
• Evaluate characteristics, management and survival in patients
• Determine the variability in practice in the use of ventilation strategies and their association with subsequent mortality among patients on ECMO.
Patients will be observed from time of admission to the ICU and up until 28 days post study enrolment. This data will give an accurate description of the characteristics and management of adult patients admitted to the ICU in Australia and New Zealand with moderate-severe ARDs. This data will be used to inform future trial design.
Intervention code [1] 313854 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319342 0
All-cause mortality assessed by telephone follow-up, searching the National Death Index, data-linkage to medical records etc.
Timepoint [1] 319342 0
Day 28
Secondary outcome [1] 367842 0
Use of adjunctive support therapy assessed by accessing information from hospital medical records.
Timepoint [1] 367842 0
Day 28
Secondary outcome [2] 367843 0
Organ failure assessed by accessing information from hospital medical records..
Timepoint [2] 367843 0
Day 7
Secondary outcome [3] 367844 0
Ventilator free days assessed by accessing information from hospital medical records.
Timepoint [3] 367844 0
Hospital discharge or day 28 whichever occurs first
Secondary outcome [4] 367846 0
ICU free days assessed by accessing information from hospital medical records.
Timepoint [4] 367846 0
Hospital discharge or day 28 whichever occurs first
Secondary outcome [5] 367847 0
DIscharge destination assessed by accessing information from hospital medical records.
Timepoint [5] 367847 0
Hospital discharge

Eligibility
Key inclusion criteria
Patients must meet all of the following inclusion criteria:
1. Age equal to or greater than 18 years
2. Patients with respiratory failure requiring invasive mechanical ventilation via an endotracheal tube or tracheostomy admitted to the ICU
3. Moderate-severe ARDS as defined by fulfilment of ALL of the following in the last 48 hours:
a. Bilateral opacities in chest x-ray or CT, not fully explained by effusion, lung collapse or nodules
b. Respiratory failure not fully explained by cardiac failure or fluid overload
c. PaO2/FiO2 ratio equal to or less than 150 with a minimum of 5 cmH2O PEEP
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis showing the frequency of practice and clinical characteristics of the study patients will be undertaken by a statistician employed for the purposes of the study.
Descriptive statistics including proportions for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables will be reported. No assumptions will be made for missing data. Proportions will be compared using chi-squared or Fisher exact tests and continuous variables will be compared using Student t test or Wilcoxon rank-sum test as appropriate.
Baseline characteristics will be analysed to determine predictors of outcome variables such as length of stay, and mortality.
Univariate and multivariate analysis using logistic regression stratified by site will be performed to determine factors associated with survival in severe ARDS and, in a subgroup analysis, compare patients admitted to and transferred to ECMO centres.
For ventilator settings such as tidal volume, values will be characterised according to clinically important cut-offs of less than or equal to 6.5 ml/kg PBW, 6.6 – 8.0 ml/kg PBW and > 8.0 ml/kg PBW.
All p values will be 2-sided, and a value of <0.05 will be considered to be statistically significant.
Sample size: we estimate that each site will enrol, on average, at least 1-2 patients per week. Assuming 25 sites participate in this study, an estimated 650 - 1300 patients will be enrolled over a 6-month period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2019
Actual
22/09/2019
Date of last participant enrolment
Anticipated
1/10/2021
Actual
17/07/2021
Date of last data collection
Anticipated
1/11/2021
Actual
15/08/2021
Sample size
Target
1000
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21329 0
New Zealand
State/province [1] 21329 0
Auckland; Christchurch; Dunedin; Nelson; Tauranga;Waikato; Wellington

Funding & Sponsors
Funding source category [1] 307870 0
University
Name [1] 307870 0
The University of Auckland
Country [1] 307870 0
New Zealand
Funding source category [2] 307871 0
University
Name [2] 307871 0
Australian National University
Country [2] 307871 0
Australia
Primary sponsor type
Individual
Name
Rachael Parke
Address
Cardiothoracic and Vascular ICU
Auckland City Hospital
PO Box 110147
Auckland Hospital
Grafton 1148
Auckland
Country
New Zealand
Secondary sponsor category [1] 302000 0
None
Name [1] 302000 0
Address [1] 302000 0
Country [1] 302000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302840 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 302840 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 302840 0
New Zealand
Date submitted for ethics approval [1] 302840 0
26/02/2019
Approval date [1] 302840 0
27/08/2019
Ethics approval number [1] 302840 0
Ethics committee name [2] 304296 0
ACT Health Human Research Ethics Committee
Ethics committee address [2] 304296 0
PO Box 11 Woden ACT 2606
Ethics committee country [2] 304296 0
Australia
Date submitted for ethics approval [2] 304296 0
01/04/2019
Approval date [2] 304296 0
10/05/2019
Ethics approval number [2] 304296 0
2019/ETH/00054

Summary
Brief summary
Acute respiratory distress syndrome (ARDS) is a condition where the lungs have become injured and do not work as they normally should to provide oxygen and remove carbon dioxide from the body. Patients may need higher levels of respiratory support and perhaps the use of a ventilator (breathing machine). Despite advances in the understanding and recognition of ARDS; novel therapies being developed and employed, ARDS can cause damage to other organs, causes a longer stay in the intensive care unit (ICU) and the hospital and significantly increases ICU costs. There is also a high risk of death at 40-50%.
Previous studies have provided great insight and helped shape our understanding of the disease, however there remains limited information about the recognition, management and outcomes of patients with ARDS. Currently limited evidence exists regarding the management and outcomes of patients with moderate-severe ARDS in Australia and New Zealand to inform future trial design. This will be the first study to report this data in Australia and New Zealand.
We plan to undertake study for 6 months in 25 ICUs in Australia and New Zealand to assess the management of moderate-severe ARDS. Trained research nurses in each ICU will collect data to describe management practises, use of ventilator strategies and additional therapies and describe outcomes in patients with moderate-severe ARDS; determine factors in early moderate-severe ARDS associated with survival; and determine the impact of artificial external heart lung machine use in these patients.
We hypothesise that this data will give an accurate description of the characteristics and management of adult patients admitted to the ICU in Australia and New Zealand with moderate-severe ARDs. This data will be used to inform future trial design to test interventions to reduce further deterioration and death in these patients.
We have a unique opportunity to prospectively collect high quality data regarding the management and outcomes of patients with moderate-severe ARDS admitted to ICUs in Australia and New Zealand. We will then compare this data to the data generated by our US colleagues to report and compare regional trends.
Study findings will be presented at national and international meetings and published in high-quality peer reviewed journals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91570 0
A/Prof Rachael Parke
Address 91570 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
PO Box 110147
Auckland Hospital
Grafton 1148
Auckland
Country 91570 0
New Zealand
Phone 91570 0
+64 21893176
Fax 91570 0
Email 91570 0
[email protected]
Contact person for public queries
Name 91571 0
Rachael Parke
Address 91571 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
PO Box 110147
Auckland Hospital
Grafton 1148
Auckland
Country 91571 0
New Zealand
Phone 91571 0
+64 21893176
Fax 91571 0
Email 91571 0
[email protected]
Contact person for scientific queries
Name 91572 0
Rachael Parke
Address 91572 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
PO Box 110147
Auckland Hospital
Grafton 1148
Auckland
Country 91572 0
New Zealand
Phone 91572 0
+64 21893176
Fax 91572 0
Email 91572 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
To be discussed by international management committee.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4688Study protocol  [email protected]
4689Ethical approval  [email protected]



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.