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)
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Published in |
Journal of Cardiothoracic Surgery, August 2016
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DOI | 10.1186/s13019-016-0530-z |
Pubmed ID | |
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 |
Abstract |
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). 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. 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. NCT02184819 (ClinicalTrials.gov). |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 47 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 10 | 21% |
Student > Bachelor | 4 | 9% |
Student > Postgraduate | 4 | 9% |
Student > Doctoral Student | 3 | 6% |
Student > Master | 3 | 6% |
Other | 5 | 11% |
Unknown | 18 | 38% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 19 | 40% |
Nursing and Health Professions | 3 | 6% |
Veterinary Science and Veterinary Medicine | 1 | 2% |
Biochemistry, Genetics and Molecular Biology | 1 | 2% |
Agricultural and Biological Sciences | 1 | 2% |
Other | 5 | 11% |
Unknown | 17 | 36% |