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Levosimendan for Veno-arterial ECMO Weaning (WEANECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323709
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Cardiogenic Shock Refractory Shock Other: Data collection Other: Data analysis

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Levosimendan for Reducing Veno-arterial ECMO Weaning Failure During Refractory Cardiogenic Shock: a Retrospective Propensity Score Analysis
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
levosimendan group
All patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible.
Other: Data collection
Clinical data are collected from the medical record of the institution. At admission, date were collected on age, gender, body mass index, Simplified Acute Physiology Score II, Sequential Organ Failure Assessment, hypertension, diabetes, hypercholesterolemia, smoking, history of stroke or congestive heart failure, coronary or peripheral artery disease, renal failure with dialysis, Left Ventricular Ejection Fraction(LVEF), Tricuspid Annular Plane Systolic Excursion, mean arterial pressure, heart rate, central venous pressure, ScvO2, presence of an intra-aortic balloon pump and biochemical parameters. During hospitalization data were collected on reason for initiation of VA-ECMO and its characteristics (duration, type, flow L/min, RPM, FiO2), length of stay in ICU, catecholamines and inotropes maximal dose and length of administration, patients with heart transplantation or LVAD. In patients with levosimendan treatment, timing of administration regarding ECMO canulation was collected

Other: Data analysis
Continuous variables were presented as mean ± standard deviation and compared using Student's t-test or Mann-Whitney U-test depending on their normality. Categorical variables were presented as counts and percentages and compared using Pearson's chi-squared test or Fisher's exact test, as appropriate. Survival at day 28 was estimated using the Kaplan-Meier method and compared using the log rank test. Investigators conducted a multivariable logistic regression with propensity score matching, which was defined as the probability of exposure to levosimendan. Results were reported as odd ratios (ORs) together its 95%CI assuming a 5% level of statistical significance. All analyses were carried out using STATA 15.0 (Stata Corp, College Station, Texas 77845 USA).

group control
All patients undergoing VA-ECMO from January 2012 to December 2018 but not treated with levosimendan were eligible.
Other: Data collection
Clinical data are collected from the medical record of the institution. At admission, date were collected on age, gender, body mass index, Simplified Acute Physiology Score II, Sequential Organ Failure Assessment, hypertension, diabetes, hypercholesterolemia, smoking, history of stroke or congestive heart failure, coronary or peripheral artery disease, renal failure with dialysis, Left Ventricular Ejection Fraction(LVEF), Tricuspid Annular Plane Systolic Excursion, mean arterial pressure, heart rate, central venous pressure, ScvO2, presence of an intra-aortic balloon pump and biochemical parameters. During hospitalization data were collected on reason for initiation of VA-ECMO and its characteristics (duration, type, flow L/min, RPM, FiO2), length of stay in ICU, catecholamines and inotropes maximal dose and length of administration, patients with heart transplantation or LVAD. In patients with levosimendan treatment, timing of administration regarding ECMO canulation was collected

Other: Data analysis
Continuous variables were presented as mean ± standard deviation and compared using Student's t-test or Mann-Whitney U-test depending on their normality. Categorical variables were presented as counts and percentages and compared using Pearson's chi-squared test or Fisher's exact test, as appropriate. Survival at day 28 was estimated using the Kaplan-Meier method and compared using the log rank test. Investigators conducted a multivariable logistic regression with propensity score matching, which was defined as the probability of exposure to levosimendan. Results were reported as odd ratios (ORs) together its 95%CI assuming a 5% level of statistical significance. All analyses were carried out using STATA 15.0 (Stata Corp, College Station, Texas 77845 USA).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Impact of exposure to levosimendan (at day 28) [ Time Frame: Day 28 ]
    Secondary endpoints were the impact of exposure to levosimendan on mortality at day 28 after VA-ECMO canulation.

  2. Impact of exposure to levosimendan (at 6 months) [ Time Frame: 6 months ]
    Secondary endpoints were the impact of exposure to levosimendan on mortality at 6 months after VA-ECMO canulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323709


Locations
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France
Hôpital Louis Pradel
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04323709    
Other Study ID Numbers: WEANECMO_2020
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Refractory cardiogenic shock
Levosimendan
VA-ECMO (Veno-Arterial ExtraCorporeal Membrane Oxygenation)
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases