Goal-directed therapy in cancer surgery: a randomised and controlled trial (GRICS II)

Methods We randomly assigned patients admitted to the ICU after major abdominal oncology surgery to receive either GDT protocol or usual care. The GDT protocol involved hemodynamic optimization aimed at a target of a cardiac index >2.5 L/minute/m2 (by minimally invasive cardiac output monitoring) and a mean arterial pressure of 70 mmHg through a three-step approach: fluid therapy of 250 ml albumin 4% in lactated Ringer ́s solution, dobutamine infusion up to a dose of 20 μg/kg/minute, and red blood cell transfusion to reach a hemoglobin level above 8g/dL. The primary outcome was a 30-day composite endpoint of acute kidney injury, major cardiovascular complications, adult respiratory distress syndrome, septic shock, reoperation and mortality. Results Of the 125 enrolled patients, 62 were assigned to GDTgroup and 63 to the usual-care group. There was no difference between groups regarding the amount of fluids received during 8 hours (1345 mL [1042-1771] vs. 1100 mL [780-1388], p = 0.151) of intervention and during 24 hours (2021 mL [1527-2844] vs. 2010 mL [17472410], p = 0.372). Patients in the GDT-group were more likely to receive dobutamine (37[66.1%] vs. 12 [23.1%], p < 0.0001). At 30 days after randomization, the composite endpoint occurred in 25.8% in the GDT group and in 22.2% in the usual-care group (p = 0.639). There was no significant difference in blood transfusion requirements, in-hospital mortality, duration of organ support, or length of hospital stay.