Clinical trials

Several drawbacks are inherent to traditional clinical trials in ICU; they are expensive, underpowered for small but important differences in mortality and patient sub-groups, take years to complete, and historically they’ve neglected to measure financial costs or long-term patient outcomes.

It’s time to think smarter and work better.

Our clinical trials are designed to meet these challenges through novel designs and by leveraging existing datasets and processes. Many are embedded in active clinical registries, allowing us to address consumer-driven research questions through low-cost design with high-impact results.

We’ll also nurture systems to maximise data usage, by engaging with national and international trials networks and registries, to align data and information sharing, and develop researcher capacity in this type of research.

Mega-ROX

  • Funding source: New Zealand HRC
  • CIA: Professor Paul Young (MRINZ)
  • Provision of mechanical ventilation is required for most critically ill patients who are admitted to an intensive care unit. Delivery of supplemental oxygen to ICU patients who require mechanical ventilation often exposes them to a high fraction of inspired oxygen (FIO2) and higher than normal arterial oxygen partial pressure (PaO2). This 40,000 participant trial is being conducted in multiple countries and includes innovative design features such as national ICU registry data linkage and response adaptive randomization to improve participant safety.

Low OxyGen Intervention for Cardiac Arrest injury Limitation trial (LOGICAL)

  • Funding source: National Health and Medical Research Council 2021 Clinical Trials and Cohort Studies Grants
  • CIA: Prof Carol Hodgson (Monash University)
  • Project Manager: Anne Mather – anne.mather@monash.edu
  • Life support with mechanical ventilation (MV) is required for most patients after cardiac arrest, however the optimal oxygen therapy in these patients is uncertain. This Phase III RCT tests standard care (liberal oxygen provision) versus a protective conservative dose of oxygen on neurological recovery after cardiac arrest.

Blend to Limit oxygEN in ECMO (BLENDER)

  • Funding source: MRFF
  • CIA: Adj. Prof David Pilcher (Monash University)
  • Growing evidence suggests high levels of oxygen may be harmful for patients needing ECMO support, and there is significant variation in clinical practice as a result of a lack of evidence-based guidelines for ECMO. In this Phase II Multicentre Randomised Controlled Trial, we will determine if using a conservative versus a liberal approach to oxygen administration improves patient outcomes.

Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO Rehab)

  • Funding source: MRFF – Cardiovascular Mission
  • CIA: Prof Carol Hodgson (Monash University)
  • While life-saving, ECMO is associated with significant complications including severe, prolonged neuromuscular weakness and increased mortality. There is a need for transforming care to improve outcomes. This study, embedded within the EXCEL Registry, assesses an early rehabilitation intervention designed to improve survival and recovery, across all ECMO centres in Australia.

Treatment of invasively ventilated adults with Early Activity and Mobilisation (TEAM)

  • Funding source: NHMRC
  • CIA: Prof Carol Hodgson (Monash University)
  • Invasive mechanical ventilation (IMV) is a life-saving intervention, however patients are typically confined to bed with no active exercise, leading to muscle wastage and prolonged hospitalization. This Phase III Randomised Controlled Trial investigates the efficacy of our bespoke early activity and mobilization intervention on physical and mental health outcomes of patients receiving IMV. With 750 participants, it is the largest trial ever conducted of early mobilization in ICUs.