Levosimendan for Veno-arterial ECMO Weaning

CompletedOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

January 31, 2019

Study Completion Date

March 1, 2020

Conditions
Cardiogenic ShockRefractory Shock
Interventions
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).

Trial Locations (1)

69500

Hôpital Louis Pradel, Bron

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT04323709 - Levosimendan for Veno-arterial ECMO Weaning | Biotech Hunter | Biotech Hunter