RESUMEN
Levosimendan is a drug with a considerable cardiotonic properties; it improve myocardial contractility without causing an increase in myocardial oxygen consumption. The aim of this randomized double blinded study was to compare the effect of levosimendan and milrinon on heamodynamic performance in patients with severe cardiac dysfunction due to acute heart failure. A total of 375 patients admitted to general I.C.U with acute heart failure with the need for hemodynamic monitoring and further hemodynamic support were allocated to this study. After exclusion of 215 patients, 160 patients were randomized to receive levosimendan [Group L, no.=81], or milrinon [Group M no.=79]. Group L patients [no.=81] received an initial loading dose of 12 micro g/kg i.v over 10 minutes, followed by a continuous infusion of 0.1 micro g/kg/min in a maximum of 0.4 micro g/min [according to hemodynamic tolerance]. Group M patients [no.=79] received a loading dose of 25 micro g/kg up to 75 micro g/kg followed by 0.375 micro g/kg/min that was escalated to 0.75 micro g/kg/min to reach satisfactory hemodynamic response. The favored target was to increase cardiac output to more than 30% of the baseline and decrease after load especially that of the right side [pulmonary artery pressure PAP] to more than -25% of the initial reading. Those hemodynamic results were expected to occur within 24 hours from starting the infusion. Hemodynamic parameters monitored were: Repeated baseline measurement of cardiac output [CO], pulmonary capillary wedge pressure [PCWP], mean right atrial pressure [CVP], mean pulmonary artery pressure [PAP] by means of pulmonary artery catheter. Cardiac index [CI], systemic vascular resistance [SVR], pulmonary vascular resistance [PVR] was calculated through hemodynamic measurements. Readings were taken 10 minutes after beginning of loading dose infusion, 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours, whilst systolic and diastolic blood pressure was continuously monitored by arterial cannula and heart rate and rhythm through ECG monitoring. The study target was achieved in 49 patients in the levosimendan group and 33 patients of the milrinone group. After tracing the study patients for 180 days, 7 patients of the levosimendan group had died, compared with 9 patients of the milrinone group. Levosimendane showed an improvement in hemodynamic performance than milrinone in case of acute heart failure and showed a lower mortality incidence than the latter drug as well