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An observational study of critically ill patients with severe acute respiratory distress syndrome.

An observational study of critically ill patients with severe acute respiratory distress syndrome in Australia and New Zealand to determine mortality.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000403134
Acronym
SAGE-ANZ
Enrollment
200
Registered
2019-03-13
Start date
2019-09-22
Completion date
2021-07-17
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Rachael Parke
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026