Journal of Clinical Trials
Open Access
ISSN: 2167-0870
+44 1478 350008
ISSN: 2167-0870
+44 1478 350008
Research Unit, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain
Review Article
Rationale and Design of a Spanish Mulicenter Randomized Controlled Trial of Use of Preoperative Levosimendan to Reduce Low Cardiac Output Syndrome (LCOS) in Low Ejection Fraction (? 35%) Cardiac Surgery Patients Spanish Randomized Clinical Trial on S
Author(s): María Ángeles Tena*, Luis Santana, Stefano Urso, Jesús María González, Dolores Fiuza, Miguel Barbeito, Federico Paredes and Francisco Portela
Background: Low Cardiac Output Syndrome (LCOS) is a complication that appears in approximately 20%of cardiac surgeries with extracorporeal circulation. This is associated with increased mortality, delayed recovery and prolonged hospital stay. The Spanish Randomized Clinical Trial on Sindax (SPARTANS) aims to demonstrate the effectiveness of the preoperative use of levosimendan in reducing LCOS in patients with poor Left Ventricle Ejection Fraction (LVEF) undergoing elective cardiac surgery.
Methods: SPARTANS study is a multicenter, randomized triple-blind, placebo-controlled trial. 300 patients with LVEF ≤ 35%, undergoing elective cardiac surgery will be recruited from 9 Spanish hospitals and randomized into two groups: Preoperative administration of levosimendan or placebo for 24 hours. The study drug will be started as a continuous infu.. View More»