Clinical trial NCT04323709: Levosimendan for Veno-arterial ECMO Weaning
Official title: Levosimendan for Reducing Veno-arterial ECMO Weaning Failure During Refractory Cardiogenic Shock: a Retrospective Propensity Score Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Refractory Shock
Keywords: Refractory cardiogenic shock
Levosimendan
VA-ECMO (Veno-Arterial ExtraCorporeal Membrane Oxygenation)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators performed a retrospective single-center cohort study. All patients undergoing VA-ECMO from January 2012 to December 2018 were eligible and divided into two groups: group levosimendan and group control (without levosimendan

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).


Eligibility criteria: 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.

Primary outcomes:
measure: VA-ECMO weaning failure defined as death
timeFrame: 24 hours
Secondary outcomes:
measure: Impact of exposure to levosimendan (at day 28)
timeFrame: Day 28
measure: Impact of exposure to levosimendan (at 6 months)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
References:
citation: Guilherme E, Jacquet-Lagreze M, Pozzi M, Achana F, Armoiry X, Fellahi JL. Can levosimendan reduce ECMO weaning failure in cardiogenic shock?: a cohort study with propensity score analysis. Crit Care. 2020 Jul 16;24(1):442. doi: 10.1186/s13054-020-03122-y.