Levosimendan for Veno-arterial ECMO Weaning (WEANECMO)

Civil Hospices of Lyon

Status: Completed

Conditions: Refractory Shock; Cardiogenic Shock

Treatments: Other: Data collection; Other: Data analysis

Study type: Observational

Funder types: Other

Identifiers

NCT04323709

WEANECMO_2020

Details and patient eligibility

About

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary mechanical circulatory support that has been increasingly used over the last decade to restore and maintain adequate end-organ perfusion, with data suggesting improvement in outcome for patients with refractory cardiogenic shock. Nevertheless, VA-ECMO weaning should be questioned every day during patient's support. Indeed, studies have shown that the incidence of severe complications related to ECMO is associated with longer circulatory support duration. Inotropes such as dobutamine are currently used to improve myocardial contractility during VA-ECMO support with the aim to enhance left ventricular ejection, aortic valve opening and to shorten ECMO duration. However, many data suggest an increase in mortality related to predisposition to myocardial ischemia and arrythmias. Levosimendan is a calcium sensitizing inotropic agent with systemic, coronary and pulmonary vasodilatory properties and specific cardioprotective effect without increasing myocardial oxygen consumption. The use of levosimendan in patients undergoing VA-ECMO may therefore be of interest both to reduce the duration of mechanical support and to minimize severe complication with few data suggesting a potential benefit of levosimendan for VA-ECMO weaning and survival in post-cardiotomy low cardiac output syndrome with improvement of endothelial function and hemodynamics. Investigators therefore sought to investigate whether the use of levosimendan improves weaning for patients undergoing VA-ECMO support for refractory cardiogenic shock hospitalized in the surgical intensive care unit (ICU).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• All consecutive patients admitted with VA-ECMO support for refractory cardiogenic shock
• All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
• Levosimendan administration was left to the discretion of the attending clinician

Exclusion criteria

• Age < 18 years
• VA-ECMO duration < 48h
• VA-ECMO for refractory cardiac arrest
• Right heart or veno-venous ECMO
• VA-ECMO for circulatory failure following lung transplant surgery.

Trial design

200 participants in 2 patient groups

levosimendan group

Description:

All patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible.

Treatment:

Other: Data analysis

Other: Data collection

group control

Description:

All patients undergoing VA-ECMO from January 2012 to December 2018 but not treated with levosimendan were eligible.

Treatment:

Other: Data analysis

Other: Data collection