Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS

Phase

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

Cernevit

Levosimendan

Clinical Study ID

NCT04158674

ELLOUZE_ORION_2018

Ages > 18
All Genders

Study Summary

Extracorporeal life support (ECLS) is a circulatory cardio supplementation technique; it therefore makes it possible to compensate for a defective cardiac or cardio-respiratory function. ECLS nevertheless remains a temporary assistance technique pending a potential recovery of cardiac function, or it can be used to direct patients towards a heart transplant or long-term circulatory assistance (Left Ventricular Assist Device (LVAD) or Total Heart). In patients with complete or partial recovery of cardiac and circulatory function, ECLS withdrawal may be considered. Withdrawal from ECLS remains a delicate phase and the risk of failure is high. The mechanism of action of levosimendan, a drug that increases the contractility of the heart, suggests that it would improve the heart-vessel connection and reduce the rate of ECLS withdrawal failure. The effect of levosimendan is maximal 24 to 48 hours after the end of the infusion and has a prolonged period of action.

The objective is to evaluate the efficacy of levosimendan administration (0.2 µg/kg/min over 24 hours) - versus placebo - prior to ECLS removal on the rate of withdrawal failure in patients under ECLS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

adult patient
patient or person responsible for the patient has given written consent
patient with acute circulatory heart failure under ECLS
patient meeting criteria for ECLS withdrawal
ECLS flow rate at 1.0-1.5l/min and/or ECLS pump rpm ≤ 1500 rpm
LVEF > 20% in cardiac ultrasound and aortic ITV > 10 cm
VIS score ≤ 10
Arterial lactates ≤ 2 mmol/l
Right ventricular outflow tract shortening fraction > 30%
Basal diameter at the tricuspid telediastolic ring of the right ventricle < 35mm
Fraction of inspired oxygen combined between ventilator and ECLS < 80%
ECLS withdrawl scheduled within 48 hours
Absence of an initial or progressive infectious episode (no planned introduction ofantibiotic therapy within 48 hours prior to inclusion)

Exclusion

Exclusion Criteria:

Patient with hepatic insufficiency: cytolysis at least 20 times normal
Drug intoxication and attempted suicide
Patient with a contraindication to the use of levosimendan:
hypersensitivity to the active substance or any of the excipients
severe hypotension and ventricular tachycardia
significant mechanical obstructions affecting ventricular filling and/orejection
severe renal failure (creatinine clearance < 30 ml/min)
severe liver failure (TP<50%)
history of torsades de pointes
Patient with a contraindication to the use of CERNEVIT®:
hypersensitivity to active substances, in particular to vitamin B1 or to one ofthe excipients or to soy protein products or to peanut protein products
hypervitaminosis to any vitamin contained in this formulation
severe hypercalcemia, hyper calciuria, tumour, bone metastasis, primaryhyperparathyroidism, granulomatosis
patient not affiliated to or not benefiting from national health insurance
patient subject to legal protection (curatorship, guardianship)
patient subject to limited judicial protection
pregnant, parturient or breastfeeding woman

Study Design