PRECISE: PRecision Ecmo in CardIogenic Shock Evaluation

Sponsor

Australian and New Zealand Intensive Care Research Centre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05748860

Collaborator

(none)

236

Enrollment

44.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock

Study Design

Study Type:

Observational

Anticipated Enrollment :

236 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PRecision Ecmo in CardIogenic Shock Evaluation

Anticipated Study Start Date :

Apr 3, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Adult patients commencing on VA-ECMO 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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Australian and New Zealand Intensive Care Research Centre

Investigators

Principal Investigator: Aidan JC Burrell, Australian and New Zealand Intensive Care Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Australian and New Zealand Intensive Care Research Centre

ClinicalTrials.gov Identifier:

NCT05748860

Other Study ID Numbers:

ANZIC-RC/AB003

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Australian and New Zealand Intensive Care Research Centre

Additional relevant MeSH terms:

Shock, Cardiogenic

Shock

Study Results

No Results Posted as of Mar 1, 2023