Journal of Clinical Trials
Open Access

Abstract

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 Sindax (Spartans Study)

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 infusion (0.1 μg/kg/ min) at least 8 hours before surgery.

The primary endpoint will be 30-day LCOS. It will be evaluated using any of the following criteria:

1) Postoperated cardiac index ≤ 2.0 L/min/m², 2) Need to implant a intra-aortic balloon pump/left ventricular assist device, 3) Vasoactive inotropic scale (VIS) >5.5.

The secondary end-point will be composite event rate at one year including the following events: death from any cause, need for renal replacement therapy or dialysis and LCOS.

The sample size is based on the assumption that levosimendan reduces LCOS by 50%.

Conclusion: The effectiveness of levosimendan has not yet been reported with a good evidence in cardiac surgery. We will test the hypothesis that levosimendan reduces LCOS in patients with compromised left ventricular function.

Trial registration number: NCT04179604 (ClinicalTrials.gov).

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 Sindax (Spartans Study)

Published Date: 2020-11-24; Received Date: 2020-11-04