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PRecision Ecmo in CardIogenic Shock Evaluation

Not yet recruiting
Conditions
Cardiogenic Shock
Registration Number
NCT05748860
Lead Sponsor
Australian and New Zealand Intensive Care Research Centre
Brief Summary

Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit.

The PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
236
Inclusion Criteria
  • Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR)
  • 18 years old or older
  • Patients who will be enrolled in the EXCEL Registry (HREC Project 534/18)
Exclusion Criteria
  • Patients who are already on ECMO, or where
  • There are inadequate resources to complete the study

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disability-free survival at day 180Day 180

Measured with the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)

Secondary Outcome Measures
NameTimeMethod
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