A randomized trial evaluating different modalities of levosimendan administration in cardiac surgery patients with myocardial dysfunction

OBJECTIVE: To evaluate the effects of 2 different administration modalities of levosimendan (start before cardiopulmonary bypass [CPB] and at the end of CPB) compared with a standard treatment with milrinone started at the end of CPB in cardiac surgery patients with a preoperative ejection fraction <30%. DESIGN: A prospective study. SETTING: A university hospital. PARTICIPANTS: Sixty patients undergoing elective cardiac surgery with CPB. INTERVENTIONS: Patients were randomly assigned to 3 different treatment options for weaning from CPB after cardiac surgery. Group A received milrinone, 0.5 microg/kg/min, after the release of the aortic cross-clamp; group B received levosimendan, 0.1 microg/kg/min, after the induction of anesthesia; and in group C, levosimendan, 0.1 microg/kg/min, was started immediately after the release of the aortic cross-clamp. In all patients, additional dobutamine, 5 microg/kg/min, was initiated after the release of the aortic cross-clamp. Norepinephrine maintained mean arterial pressure constant. MEASUREMENTS AND MAIN RESULTS: Stroke volume after surgery was initially higher than at baseline in all groups and highest in group B. Stroke volume declined 12 hours after surgery in group A but not in groups B and C (p < 0.05 between groups), despite similar filling pressures. Four patients in group A, none in group B, and 1 in group C died within 30 days of surgery. Postoperative atrial fibrillation was observed in 10 patients in group A, 7 patients in group C, and only 1 in group B (p < 0.01). No differences were observed in postoperative troponin I release among groups. CONCLUSION: In the conditions of the present study, starting the levosimendan treatment before CPB was associated with a higher initial postoperative stroke volume and a lower incidence of postoperative atrial fibrillation, but had no effect on the extent of postoperative troponin I release