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NCT05748860 Clinical Trial

PRecision Ecmo in CardIogenic Shock Evaluation

Cardiogenic Shock Clinical Trial

— PRECISE  

Official title:
PRecision Ecmo in CardIogenic Shock Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05748860
Other study ID # ANZIC-RC/AB003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 3, 2023
Est. completion date December 31, 2026

Study information
Verified date February 2023
Source Australian and New Zealand Intensive Care Research Centre
Contact Sheraya De Silva
Phone +61 3 9903 0343
Email sheraya.desilva@monash.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 236
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Australian and New Zealand Intensive Care Research Centre

Outcome
Type Measure Description Time frame Safety issue
Primary Disability-free survival at day 180 Measured with the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0) Day 180
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