PRecision Ecmo in CardIogenic Shock Evaluation (PRECISE)

Australian and New Zealand Intensive Care Research Centre

Status: Not yet enrolling

Conditions: Cardiogenic Shock

Study type: Observational

Funder types: Other

Identifiers

NCT05748860

ANZIC-RC/AB003

Details and patient eligibility

About

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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

236 participants in 1 patient group

Adult patients commencing on VA-ECMO

Description:

The study population is adult patients on VA-ECMO for cardiogenic shock or cardiac arrest that are or will be enrolled in the national ECMO registry (EXCEL).