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Clinical Trials/NCT04323709
NCT04323709
Completed
Not Applicable

Levosimendan for Reducing Veno-arterial ECMO Weaning Failure During Refractory Cardiogenic Shock: a Retrospective Propensity Score Analysis

Hospices Civils de Lyon1 site in 1 country200 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiogenic Shock
Sponsor
Hospices Civils de Lyon
Enrollment
200
Locations
1
Primary Endpoint
VA-ECMO weaning failure defined as death
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
March 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

VA-ECMO weaning failure defined as death

Time Frame: 24 hours

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

Secondary Outcomes

  • Impact of exposure to levosimendan (at day 28)(Day 28)
  • Impact of exposure to levosimendan (at 6 months)(6 months)

Study Sites (1)

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