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Open Access 01-12-2016 | Study protocol

Rationale and design of the multicenter randomized trial investigating the effects of levosimendan pretreatment in patients with low ejection fraction (≤40 %) undergoing CABG with cardiopulmonary bypass (LICORN study)

Authors: Thibaut Caruba, Delphine Hourton, Brigitte Sabatier, Dominique Rousseau, Annick Tibi, Cécile Hoffart-Jourdain, Akim Souag, Nelly Freitas, Mounia Yjjou, Carla Almeida, Nathalie Gomes, Pascaline Aucouturier, Juliette Djadi-Prat, Philippe Menasché, Gilles Chatellier, Bernard Cholley

Published in: Journal of Cardiothoracic Surgery | Issue 1/2016

Abstract

Background

Patients with a left ventricular ejection fraction (LVEF) of less than 40 % are at high risk of developing postoperative low cardiac output syndrome (LCOS). Despite actual treatments (inotropic agents and/or mechanical assist devices), the mortality rate of such patients remains very high (13 to 24 %). The LICORN trial aims at assessing the efficacy of a preoperative infusion of levosimendan in reducing postoperative LCOS in patients with poor LVEF undergoing coronary artery bypass grafting (CABG).

Methods/Design

LICORN study is a multicenter, randomized double-blind, placebo-controlled trial in parallel groups. 340 patients with LVEF ≤40 %, undergoing CABG will be recruited from 13 French hospitals. The study drug will be started after anaesthesia induction and infused over 24 h (0.1 μg/kg/min).

The primary outcome (postoperative LCOS) is evaluated using a composite criterion composed of: 1) need for inotropic agents beyond 24 h following discontinuation of the study drug; 2) need for post-operative mechanical assist devices or failure to wean from these techniques when inserted pre-operatively; 3) need for renal replacement therapy. Secondary outcomes include: 1) mortality at Day 28 and Day 180; 2) each item of the composite criterion of the primary outcome; 3) the number of “ventilator-free” days and “out of intensive care unit” days at Day 28.

Discussion

The usefulness of levosimendan in the perioperative period has not yet been documented with a high level of evidence. The LICORN study is the first randomized controlled trial evaluating the clinical value of preoperative levosimendan in high risk cardiac surgical patients undergoing CABG.

Trial registration number

NCT02184819 (ClinicalTrials.gov).

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Title: Rationale and design of the multicenter randomized trial investigating the effects of levosimendan pretreatment in patients with low ejection fraction (≤40 %) undergoing CABG with cardiopulmonary bypass (LICORN study)
Authors: Thibaut Caruba
Delphine Hourton
Brigitte Sabatier
Dominique Rousseau
Annick Tibi
Cécile Hoffart-Jourdain
Akim Souag
Nelly Freitas
Mounia Yjjou
Carla Almeida
Nathalie Gomes
Pascaline Aucouturier
Juliette Djadi-Prat
Philippe Menasché
Gilles Chatellier
Bernard Cholley
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Journal of Cardiothoracic Surgery / Issue 1/2016
Electronic ISSN: 1749-8090
DOI: https://doi.org/10.1186/s13019-016-0530-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Rationale and design of the multicenter randomized trial investigating the effects of levosimendan pretreatment in patients with low ejection fraction (≤40 %) undergoing CABG with cardiopulmonary bypass (LICORN study)

Abstract

Background

Methods/Design

Discussion

Trial registration number

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration number

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