A randomized controlled trial to evaluate goal directed therapy in high-risk patients undergoing cardiac surgery

INTRODUCTION: The objective of the study was to evaluate the effects of goal-directed therapy on outcomes in high-risk patients undergoing cardiac surgery. METHODS: A prospective randomized controlled trial that evaluated 126 patients undergoing coronary artery bypass or valve repair in a Surgical Intensive Care Unit (ICU) of the Heart Institute/Faculty of Medicine of University of Sao Paulo. Patients were randomized to a cardiac output-guided hemodynamic therapy algorithm (GDT group, n=62) or to usual care (n=64). In the GDT arm, a cardiac index of greater than 3 L/min/m2 was targeted with intravenous fluids, inotropes and red blood cell transfusion starting from cardiopulmonary bypass and ending eight hours after arrival to the ICU. RESULTS: The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. Patients from the GDT group received a greater median (interquartile range) volume of intra-venous fluids than the usual care group [1000 (625 - 1500) vs. 500 (500 - 1000) mL (P<0.001)], with no differences in the administration of either inotropes or red blood cell transfusions. The primary outcome was reduced in the GDT group (27.4 vs. 45.3%, p=0.037). The GDT group had a lower incidence of infection (12.9 vs. 29.7%, P=0.002) and low cardiac output syndrome (6.5 vs. 26.6%, P=0.002). We also observed lower ICU cumulative dosage of dobutamine (12 vs. 19 mg/Kg, P=0.003) and a shorter ICU (3 [3-4] vs. 5 [4-7] days; P < 0.001) and hospital length of stay (9 [8-16] vs. 12 [9-22] days, P=0.049) in the GDT compared to the usual care group. There were no differences in 30-day mortality rates (4.8% vs. 9.4%, respectively; P = 0.492). CONCLUSIONS: Goal directed therapy using fluids, inotropes and blood transfusion reduced 30-day major complications in high-risk patients undergoing cardiac surgery