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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

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS
Official Title  ICMJE Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS. Randomized, Controlled, Multicenter, Double-blind, Multicenter Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Decompensated Heart Failure
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Levosimendan
    Intervention: Drug: Levosimendan
  • Sham Comparator: Placebo
    Intervention: Drug: Cernevit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
206
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed Omar ELLOUZE 03.80.29.32.62 ext +33 mohamedomar.ellouze@chu-dijon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04158674
Other Study ID Numbers  ICMJE ELLOUZE_ORION_2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP