Levosimendan improves renal outcome in cardiac surgery: a randomized trial

Abstract

Objective: The effect of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery was investigated.

Design: A prospective, double-blinded, randomized clinical trial.

Setting: Tertiary teaching and research hospital.

Participants: Of a total of 147 patients, 128 patients completed the study. In the levosimendan group (n = 64), levosimendan was administered in addition to standard inotropic support; whereas, in the control group (n = 64), only standard inotropic support was given.

Interventions: In the levosimendan group, a loading dose of levosimendan (6 μg/kg) was administered after removal of the aortic cross-clamp, followed by an infusion (0.1 μg/kg/min) in addition to standard inotropic therapy for 24 hours. In the control group, only standard inotropic therapy was administered. Preoperative characteristics, serum creatinine (sCr) levels, and estimated glomerular filtration rate (eGFR) were determined preoperatively, on postoperative days 1, 3, and 10. Independent risk factors for renal replacement therapy (RRT) requirement were investigated with stepwise multivariate logistic regression analysis.

Measurements and main results: The primary endpoint was the effect of levosimendan on postoperative renal clearance (sCr and eGFR). The secondary endpoint was the effect of levosimendan on clinical outcomes (length of intensive care unit and hospital stays, need for RRT). Preoperative characteristics and eGFR were similar between the groups (p>0.05). On postoperative days 1 and 3, sCr values were lower and eGFR values were higher in the levosimendan group in comparison with the control group (p = 0.0001, p = 0.009, respectively). Six patients (9.4%) in the levosimendan group and 10 patients (15.6%) in the control group required RRT therapy (p = 0.284). Independent risk factors for need of RRT include preoperative sCr value between 1.2 to 2.09 mg/dL and≥2.1 mg/dL (p< 0.05).

Conclusions: Perioperative treatment with levosimendan in addition to standard inotropic therapy in patients with a low ejection fraction undergoing mitral valve surgery improved immediate postoperative renal function and reduced need for RRT.

Keywords: cardiopulmonary bypass; ejection fraction; estimated glomerular filtration rate; levosimendan; mitral valve surgery; serum creatinine.