Levosimendan for Veno-arterial ECMO Weaning

Completed

• Conditions: Cardiogenic Shock; Refractory Shock
• Interventions: Other: Data collection; Other: Data analysis

• Registration Number: NCT04323709
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-01-31
• Status Verified: 2020-03
• Study Completion: 2020-03-01
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-25
• Last Update Submitted: 2020-03-25
• Study First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group control	Data analysis	All patients undergoing VA-ECMO from January 2012 to December 2018 but not treated with levosimendan were eligible.
levosimendan group	Data collection	All patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible.
levosimendan group	Data analysis	All patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible.
group control	Data collection	All patients undergoing VA-ECMO from January 2012 to December 2018 but not treated with levosimendan were eligible.

Primary Outcome Measures

Name	Time	Method
VA-ECMO weaning failure defined as death	24 hours	The primary endpoint was VA-ECMO weaning failure defined as death during ECMO support or death within 24h after ECMO removal.

Secondary Outcome Measures

Name	Time	Method
Impact of exposure to levosimendan (at day 28)	Day 28	Secondary endpoints were the impact of exposure to levosimendan on mortality at day 28 after VA-ECMO canulation.
Impact of exposure to levosimendan (at 6 months)	6 months	Secondary endpoints were the impact of exposure to levosimendan on mortality at 6 months after VA-ECMO canulation.

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Bron, France