PRecision Ecmo in CardIogenic Shock Evaluation

NCT05748860 | Not Yet Recruiting

• 1 other identifier: ANZIC-RC/AB003
• Study Type: observational
• Target: 236
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiogenic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disability-free survival at day 180

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

  Day 180

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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: HREC Project 534/18).

You may qualify if:

• Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR)
• years old or older
• Patients who will be enrolled in the EXCEL Registry (HREC Project 534/18)

You may not qualify if:

• Patients who are already on ECMO, or where
• There are inadequate resources to complete the study

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

Biospecimen

Retention: SAMPLES WITH DNA

The biomarkers of interest for the PRECISE Study include biomarkers involved in neuroprognositication (neuron specific enolase, neurofilament), mortality prediction (lactate), heart failure (Troponin, pro BNP), endothelial damage (Angiopoietin 2), inflammation and other biomarkers that may be involved in risk prediction. We will also collect samples of free genetic material (eg free mitochondria), which will not involve genome wide association, and therefore will not include information about heritable diseases in families.

MeSH Terms

Conditions

Shock, Cardiogenic; Critical Illness

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Disease Attributes

Study Officials

• Aidan JC Burrell

  Australian and New Zealand Intensive Care Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheraya De Silva

CONTACT

+61 3 9903 0343; sheraya.desilva@monash.edu

Victoria King

CONTACT

+61 3 9905 6646; victoria.king@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 1, 2023

Record last verified: 2023-02