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

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ClinicalTrials.gov Identifier: NCT04158674
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Drug: Levosimendan Drug: Cernevit Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS. Randomized, Controlled, Multicenter, Double-blind, Multicenter Clinical Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: Levosimendan Drug: Levosimendan
Levosimendan 2.5mg/ml, solution to be diluted for infusion Dilution in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min

Sham Comparator: Placebo Drug: Cernevit
mixture of 12 vitamins The dilution of the treatment is done in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min




Primary Outcome Measures :
  1. ECLS withdrawal failure [ Time Frame: 7 days after ECLS removal ]
    Withdrawal failure is defined as the absence of ECLS discontinuation or the use of temporary circulatory assistance such as ECLS, Impella® pump or intra-aortic balloon pump (IABP) or death



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

Inclusion Criteria:

  • adult patient
  • patient or person responsible for the patient has given written consent
  • patient with severe chronic heart failure in acute decompensation 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 < 35 mm
    • 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 of antibiotic therapy within 48 hours)

Exclusion Criteria:

  • Patient with hepatic insufficiency: cytolysis at least 20 times normal
  • 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/or ejection
    • 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 of the 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, primary hyperparathyroidism, 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

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): NCT04158674


Contacts
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Contact: Mohamed Omar ELLOUZE 03.80.29.32.62 ext +33 mohamedomar.ellouze@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Contact: Mohamed Omar ELLOUZE    03 80 29 32 62 ext +33    mohamedomar.ellouze@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04158674    
Other Study ID Numbers: ELLOUZE_ORION_2018
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs