Levosimendan for Veno-arterial ECMO Weaning

NCT04323709 | Completed

• 1 other identifier: WEANECMO_2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiogenic Shock; Refractory Shock

Keywords

Refractory cardiogenic shock; Levosimendan; VA-ECMO (Veno-Arterial ExtraCorporeal Membrane Oxygenation)

Outcome Measures

Primary Outcomes (1)

• VA-ECMO weaning failure defined as death

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

  24 hours

Secondary Outcomes (2)

• Impact of exposure to levosimendan (at day 28)

  Day 28

• Impact of exposure to levosimendan (at 6 months)

  6 months

Study Arms (2)

levosimendan group

All patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible.

Other: Data collection; Other: Data analysis

group control

All patients undergoing VA-ECMO from January 2012 to December 2018 but not treated with levosimendan were eligible.

Other: Data collection; Other: Data analysis

Interventions

Data collection OTHER

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

group control; levosimendan group

Data analysis OTHER

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; levosimendan group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 32677985 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic; Shock

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 26, 2020
• Study Start: January 1, 2019
• Primary Completion: January 31, 2019
• Study Completion: March 1, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

FR (1)