Effect of dopexamine on outcome after major abdominal surgery: A prospective, randomized, controlled multicenter study

Objective: To test the hypothesis that dopexamine reduces postoperative mor tality and morbidity in high-risk, major abdominal surgery patients, when g iven to fluid-resuscitated patients starting before the operation and conti nued for 24 hrs after surgery. Design: Prospective, randomized, controlled, double-blind multicenter trial , Setting: intensive care units in 13 hospitals from six European countries. Patients: A total of 412 patients with predefined high-risk criteria, under going major abdominal surgery with an expected duration of at least 1.5 hrs . Interventions: The patients received placebo (n = 140), dopexamine at 0.5 m u g/kg/min (n = 135), or dopexamine at 2.0 mu g/kg/min (n = 137) starting a fter preoperative hemodynamic stabilization and continued for 24 hrs after surgery. Measurements and Main Results: The primary outcome variable was mortality a t 28 days, Analysis was by intention to treat, Dopexamine had no effect on mortality (at 28 days, 13%, 7%, and 15%, for the groups receiving placebo, dopexamine at 0.5 mu g/kg/min, and dopexamine at 2.0 mu g/kg/min, respectiv ely), despite the expected dose-dependent hemodynamic responses. No effect was observed on the occurrence of organ dysfunction, duration of intensive care unit stay, or length of hospital stay. Conclusion: We conclude that dopexamine in doses that result in increased c ardiac output and oxygen delivery after preoperative stabilization with flu ids does not improve outcome after major abdominal surgery compared with fl uids alone. Based on post hoc subgroup analysis and stratification accordin g to the number of risk factors, we suggest that the concept should be furt her tested in patients at higher risk of complications or undergoing emerge ncy surgery.