6/28/23, 10:34 PM FEDORA Pathway Feedback Search Clinical Topics Home Studies FEDORA FEDORA Trial question What is the effect of esophageal Doppler monitor-guided goal-directed hemodynamic therapy among low-moderate risk patients undergoing intermediate-risk surgery? Study design Multi-center Single blinded RCT Population Characteristics of study participants 38.3% female N = 450 61.7% male 450 patients (160 female, 260 male) Inclusion criteria: adult patients scheduled for major elective surgery Key exclusion criteria: emergency surgery, ASA physical status > 3, contraindications for esophageal Doppler monitor intervention, aortic pathology Interventions N=224 goal-directed hemodynamic therapy (the intraoperative goals to maintain a maximal stroke volume, with mean arterial pressure > 70 mmHg, and cardiac index 2.5 litres/min/m using esophageal Doppler monitor) N=226 control (continuous infusion of Ringer's lactate at 3-5 mL/kg/hour for laparoscopic surgery, or 5-7 mL/kg/hour for open surgery without cardiac output monitoring) Primary outcome Rate of moderate or severe postoperative complications during the first 180 days after surgery 16.6 % 16.6 12.5 % 8.6 8.3 % Significant decrease 4.2 % https://web.pathway.md/studies/recNUmCuHsa4X7ZNj 1/2 6/28/23, 10:34 PM FEDORA Pathway NNT = 12 0.0 % Goal-directed hemodynamic therapy Control Significant decrease in the rate of moderate or severe postoperative complications during the first 180 days after surgery (8.6% vs. 16.6%; OR 0.48, 95% CI 0.27 to 0.89) Secondary outcomes Significant decrease in time to oral tolerance (1 day vs. 2 day; AD -1 day, 95% CI -1.59 to -0.41) Significant decrease in time to ambulation (2 days vs. 3 days; AD -1 days, 95% CI -1.59 to -0.41) Significant decrease in length of hospital stay (5 days vs. 7 days; AD -2 days, 95% CI -3.19 to -0.81) Safety outcomes No significant difference in death at 180 days. Significant difference in ICU length of stay (16 hours vs. 24 hours). Conclusion In adult patients scheduled for major elective surgery, goal-directed hemodynamic therapy was superior to control with respect to the rate of moderate or severe postoperative complications during the first 180 days after surgery. Reference J M Calvo-Vecino, J Ripoll s-Melchor, M G Mythen et al. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. Open reference URL https://web.pathway.md/studies/recNUmCuHsa4X7ZNj 2/2