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Research paper thumbnail of Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)

British Journal of Anaesthesia

Background: The aim of this study was to evaluate postoperative complications in patients having ... more Background: The aim of this study was to evaluate postoperative complications in patients having major elective surgery using Oesophageal Doppler Monitor (ODM) guided Goal-Directed Hemodynamic Therapy (GDHT), in which administration of fluids, inotropes, and vasopressors was guided by stroke volume (SV), mean arterial pressure (MAP), and cardiac index (CI). Methods: This was a prospective, multicentre, randomized, parallel-group, controlled patient-and observer-blind trial (ISRCTN93543537) conducted in adults scheduled for major elective surgery. Randomization and allocation were carried out by central computer system. In the control group, intraoperative fluids were given based on traditional principles. In the GDHT group, the intraoperative goals were to maintain a maximal SV, with MAP > 70mmHg, and CI  2.5 L*min-1 *m-2. The primary outcome was percentage of patients with postoperative complications during the first 180 days after surgery. Results: 450 patients were randomized to the GDHT group (n=224) or to the control group (n=226). Data from 428 patients were analysed. The percentage of patients with complications was significantly lower in the GDHT group (15% vs.27.6% p=0.001). There were also fewer specific complications (acute kidney disease, pulmonary oedema, respiratory distress syndrome, wound infections etc), and the length of hospital stay was shorter in the GDHT group. Conclusions: ODM-guided GDHT using SV, CI and MAP decreased postoperative complications in patients having major surgery.

Research paper thumbnail of Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)

British Journal of Anaesthesia

Background: The aim of this study was to evaluate postoperative complications in patients having ... more Background: The aim of this study was to evaluate postoperative complications in patients having major elective surgery using Oesophageal Doppler Monitor (ODM) guided Goal-Directed Hemodynamic Therapy (GDHT), in which administration of fluids, inotropes, and vasopressors was guided by stroke volume (SV), mean arterial pressure (MAP), and cardiac index (CI). Methods: This was a prospective, multicentre, randomized, parallel-group, controlled patient-and observer-blind trial (ISRCTN93543537) conducted in adults scheduled for major elective surgery. Randomization and allocation were carried out by central computer system. In the control group, intraoperative fluids were given based on traditional principles. In the GDHT group, the intraoperative goals were to maintain a maximal SV, with MAP > 70mmHg, and CI  2.5 L*min-1 *m-2. The primary outcome was percentage of patients with postoperative complications during the first 180 days after surgery. Results: 450 patients were randomized to the GDHT group (n=224) or to the control group (n=226). Data from 428 patients were analysed. The percentage of patients with complications was significantly lower in the GDHT group (15% vs.27.6% p=0.001). There were also fewer specific complications (acute kidney disease, pulmonary oedema, respiratory distress syndrome, wound infections etc), and the length of hospital stay was shorter in the GDHT group. Conclusions: ODM-guided GDHT using SV, CI and MAP decreased postoperative complications in patients having major surgery.