Laboratory research

BLENDER

Biobanking has been used to great success in cancer research in Australia, but it’s use in ICU research settings has been limited. The potential is huge – a recent international biobank study showed serum neurofilament light chain levels (NFL) measured at 24 hours after cardiac arrest was a more sensitive and specific marker for stratification of critically ill patients to predict poor neurological outcome than any other established test.

Our BLENDER trial is the world’s largest ECMO-related Randomised Controlled Trial, and we’re collecting blood samples for biobanking, as well as extensive physiological and clinical data from 50 per cent of participants.

We’re also investigating a range of biomarkers within large clinical trials that will aid with future patient stratification for neurological and physical recovery. These biomarkers will focus on neurological damage, and injury to the heart, kidneys and liver, and will allow doctors to make more personalised treatment choices.

Further information can be viewed at monash.edu/medicine/sphpm/anzicrc/research/blender-study

Publication

Burrell A, Bailey MJ, Bellomo R, Buscher H, Eastwood G, Forrest P, Fraser JF, Fulcher B, Gattas D, Higgins AM, Hodgson CL, Litton E, Martin EL, Nair P, Ng SJ, Orford N, Ottosen K, Paul E, Pellegrino V, Reid L, Shekar K, Totaro RJ, Trapani T, Udy A, Ziegenfuss M, Pilcher D; BLENDER Trial Investigators, EXCEL Registry, ECMONet and the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group and Centre for Outcomes and Resource Evaluation. Conservative or liberal oxygen targets in patients on venoarterial extracorporeal membrane oxygenation. Intensive Care Medicine. 2024 Sep;50(9):1470-1483. doi: 10.1007/s00134-024-07564-8.

PRECISE

PRECISE is prospective, multicentre, cohort study that is embedded within our pre-existing national ECMO registry (EXCEL). The PRECISE study aims to enhance cardiogenic shock patient care supported by extracorporeal membrane oxygenation (ECMO) by leveraging biomarkers for personalised treatment. Cardiogenic shock is a critical condition with high mortality rates, affecting about 10% of acute myocardial infarction patients in Australia. While ECMO is a life-saving option, its usage is associated with high costs, limited accessibility, and challenges in patient selection.

This study will determine whether specific biomarkers can be used to prognosticate clinical outcomes during ECMO. It will also investigate whether important clinical subphenotypes of cardiogenic shock can be defined using biomarkers, and whether these have distinct clinical characteristics. These outcomes include important patient centred outcomes, such as mortality, health status, and function at 180 days.

By harnessing the potential of biomarkers, the PRECISE study aims to revolutionise ECMO management. Biomarkers, which have transformed diagnostics and treatment strategies in complex diseases, will enable precise patient stratification and tailored treatment pathways. The study emphasises the significance of longitudinal biomarker assessment for a comprehensive understanding of patients' conditions and trajectories.

Further information can be viewed at monash.edu/medicine/sphpm/anzicrc/research/precise

NICE-Data

The National Intensive Care Data (NICE-Data) Infrastructure Initiative aims to address the critical gaps in intensive care data for critically ill patients in Australia. By linking existing registries, clinical trials, and a biobank, NICE-Data will establish a comprehensive research data infrastructure. This initiative will enable informed clinical decision-making, improved care, risk prediction tools, reduced complications, improved long-term survival rates with reduced disability, and cost optimisation.

NICE-Data will enhance the use of existing data and make it more accessible across different stages of care and generate new research data infrastructure by synthesising and linking information throughout the entire care trajectory. NICE-Data seeks to address unmet needs in areas such as complications, disability, long-term survival, risk prediction, and costs of care in critically ill patients.

Moreover, the initiative includes the development of a national website for immediate dissemination of data, along with tools for data visualisation, risk prediction, and benchmarking. NICE-Data will enable novel initiatives and methodologies for improving critical care resource utilisation, including systematic national data collection, linkage with clinical registries, evaluation of current practices, adverse event reporting, decision-making tools, and measurement of long-term outcomes and costs. Furthermore, Australia’s first registry-embedded platform clinical trial in the intensive care unit will be embedded with NICE-Data, providing new knowledge to inform early interventions and their impact on long-term outcomes.

ECMO-PROMPT

Extracorporeal membrane oxygenation (ECMO) is an invasive and expensive device used to support critically ill patients who have suffered cardiac arrest, cardiac failure or respiratory failure. ECMO acts as one of the most advanced forms of life support, replacing the function of the heart or lungs by oxygenating the blood and removing carbon dioxide, allowing time for the heart and/or lung to recover. The use of ECMO in ICU is increasing rapidly, both in Australia and globally. Whilst ECMO therapy is lifesaving, data suggests for those patients that do not survive ECMO, many are left suffering disability and poor quality of life for prolonged period of time following hospital discharge. Despite the high-cost burden of ECMO therapy, there have been no trials that aim to improve the long-term outcomes for survivors. There is a clear need to consider interventions which can improve patient care following ICU and hospital discharge.

The use of patient-reported outcome measure (PROM) monitoring and feedback has provided promising results in other medical specialties, such as oncology (cancer research). PROMs can be thought of as self-reported questionnaires where patients answer a series of questions relating to their physical and mental state at various points in time. Results from oncology trials are highly encouraging, showing PROMs monitoring and feedback contributes to earlier detection of symptoms; improves communication between clinicians and patients; improves patient quality of life and emotional well-being; and even increases patient survival (when compared to usual care). Whilst results are encouraging in the field of oncology, there is no such evidence to support the use of PROMs monitoring and feedback for the cohort of ECMO survivors.

ECMO-PROMPT is a multicentre, randomised, controlled feasibility trial that aims to determine whether providing early feedback of PROMs to patients and their primary care practitioners at various time-points following hospital discharge is a feasible intervention to improve the long-term outcomes (disability, QoL, physical and cognitive function) of ECMO survivors. Results will determine the feasibility of the intervention for a national multicentre trial and indicate if early feedback of PROMs to patients and primary care clinicians reduces ongoing disability and improves health-related QoL for ECMO survivors when compared to standard care.