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Clinical Trial Summary

ICU patients with severe heart or lung failure may require an external device called extra-corporeal membrane oxygenation (ECMO) to oxygenate their blood. The use of ECMO is rapidly increasing. It has the capability to completely replace a non-functioning heart or lungs for days to weeks, but ECMO patients only have a 42% hospital survival rate. ECMO use is associated with significant costs and risks, and it needs experienced staff. To better manage this complex intervention, the investigators need to have quality data on patients who require ECMO.

The aim of EXCEL is to create a bi-national network of integrated care that will identify best practice and cost effectiveness for patients suffering from acute cardiac failure, lung failure, or cardiac arrest and require ECMO. The investigators will collect information on 525 ECMO patients while in the ICU and the investigators aim to utilise telephone follow-up of survivors to assess disability free survival, quality of life and other long term outcomes at 6 and 12 months. Information collected will be stored in the EXCEL database and will be periodically reviewed to address safety concerns, clinical questions and process of care issues. Data will be collected over a 3 year period.

Clinical Trial Description

Each year around 130,000 Australians and New Zealanders are admitted to an intensive care unit (ICU). The sickest patients in the ICU who have severe failure of the heart or lungs may require an external machine to oxygenate their blood in addition to a mechanical ventilator. This intervention, called extracorporeal membrane oxygenation (ECMO), involves circulating all of the patient's blood through large cannulae to external machinery every minute. It has the capability of completely replacing a non-functioning heart or lungs for days to weeks on end. These critically ill patients who require ECMO are the sickest in the hospital with only 42% hospital survival. The use of ECMO has doubled in Australia and New Zealand and globally over five years, and in the USA has increased by 433%.

The use of ECMO is associated with significant costs and risks, and it requires specialist training and expertise. In order to prepare for the organisation of these complex interventions in the ICU across regions, the investigators need to have accurate data on patients undergoing ECMO. At present, clinicians, hospital administrators, and government/health policy stakeholders cannot accurately plan or organise an optimal system for the allocation and provision of ECMO to patients who need it.

The investigators will deliver a step change to the care of patients requiring ECMO by: first, monitoring and reviewing current practice in ECMO services by providing robust bi-national registry data to service providers and clinicians with a closed-loop feedback system; second, identifying gaps between evidence and practice, particularly in the areas of organisational structure, patient selection, equipment and safety; third, exploring barriers and enablers to evidence-based care in ECMO services; fourth, providing a national platform to embed clinical trials; and finally, collaborating across bi-national and international partners. The investigators will translate findings with greater capacity, reach, and impact to drive measureable change in practice and improve patient-centred outcomes.

The EXCEL Partnership represents a novel, coordinated effort to create a high-quality, detailed, prospective registry of patients requiring ECMO at ECMO centres. A tailored, detailed ECMO registry (EXCEL) can be used to address specific safety concerns, clinical questions and process of care issues. As a result, EXCEL can be designed and implemented to answer new investigator-initiated, hypothesis-driven clinical questions.

The aim is to generate a bi-national multidisciplinary network of integrated care for patients suffering acute cardiac or respiratory failure or cardiac arrest requiring extracorporeal membrane oxygenation (ECMO) to monitor long term outcomes and identify best practice. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03793257
Study type Observational [Patient Registry]
Source Australian and New Zealand Intensive Care Research Centre
Contact Carol L Hodgson, PhD
Phone +613 9903 0598
Status Not yet recruiting
Start date February 1, 2019
Completion date September 30, 2023

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