UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

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

Calvo-Vecino, JM; Ripollés-Melchor, J; Mythen, MG; Casans-Francés, R; Balik, A; Artacho, JP; Martínez-Hurtado, E; ... FEDORA Trial Investigators Group; + view all (2018) 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 , 120 (4) pp. 734-744. 10.1016/j.bja.2017.12.018. Green open access

[thumbnail of Mythen FEDORA as submitted to BJA.pdf]
Preview
Text
Mythen FEDORA as submitted to BJA.pdf - Accepted Version

Download (845kB) | Preview

Abstract

Background The aim of this study was to evaluate postoperative complications in patients having major elective surgery using oesophageal Doppler monitor-guided goal-directed haemodynamic therapy (GDHT), in which administration of fluids, inotropes, and vasopressors was guided by stroke volume, mean arterial pressure, and cardiac index. Methods The FEDORA trial was a prospective, multicentre, randomised, parallel-group, controlled patient- and observer-blind trial conducted in adults scheduled for major elective surgery. Randomization and allocation were carried out by a 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 stroke volume, with mean arterial pressure >70 mm Hg, and cardiac index ≥2.5 litres min−1 m−2. The primary outcome was percentage of patients with moderate or severe postoperative complications during the first 180 days after surgery. Results In total, 450 patients were randomized to the GDHT group (n=224) or control group (n=226). Data from 420 subjects were analysed. There were significantly fewer with complications in the GDHT group (8.6% vs 16.6%, P=0.018). There were also fewer complications (acute kidney disease, pulmonary oedema, respiratory distress syndrome, wound infections, etc.), and length of hospital stay was shorter in the GDHT group. There was no significant difference in mortality between groups. Conclusions Oesophageal Doppler monitor-guided GDHT reduced postoperative complications and hospital length of stay in low–moderate risk patients undergoing intermediate risk surgery, with no difference in mortality at 180 days.

Type: Article
Title: Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.bja.2017.12.018
Publisher version: https://doi.org/10.1016/j.bja.2017.12.018
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Elective Surgical Procedures/adverse effects, Hemodynamics/physiology, Intraoperative/methods, Postoperative Complications/prevention & control, Prospective Studies
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Infection, Immunity and Inflammation Dept
URI: https://discovery.ucl.ac.uk/id/eprint/10071827
Downloads since deposit
174Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item