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PRecision Ecmo in CardIogenic Shock Evaluation

PRecision Ecmo in CardIogenic Shock Evaluation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05748860
Acronym
PRECISE
Enrollment
236
Registered
2023-03-01
Start date
2023-04-03
Completion date
2026-12-31
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock

Keywords

ECMO, cardiogenic shock, ECPR, critical illness, intensive care

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.

Interventions

None listed

Sponsors

Australian and New Zealand Intensive Care Research Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Disability-free survival at day 180Day 180Measured with the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)

Contacts

Primary ContactSheraya De Silva
sheraya.desilva@monash.edu+61 3 9903 0343
Backup ContactVictoria King
victoria.king@monash.edu+61 3 9905 6646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026