- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323709
Levosimendan for Veno-arterial ECMO Weaning (WEANECMO)
March 25, 2020 updated by: Hospices Civils de Lyon
Levosimendan for Reducing Veno-arterial ECMO Weaning Failure During Refractory Cardiogenic Shock: a Retrospective Propensity Score Analysis
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bron, France, 69500
- Hopital Louis Pradel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
levosimendan group
All patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible.
|
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
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.
|
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
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Day 28
|
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.
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
January 31, 2019
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
March 6, 2020
First Submitted That Met QC Criteria
March 25, 2020
First Posted (Actual)
March 26, 2020
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEANECMO_2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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