Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)
J M Calvo-Vecino, J Ripollés-Melchor, M G Mythen, R Casans-Francés, A Balik, J P Artacho, E Martínez-Hurtado, A Serrano Romero, C Fernández Pérez, S Asuero de Lis, FEDORA Trial Investigators Group, Ana Tirado Errazquin, Cristina Gil Lapetra, Ane Abad Motos, Elena Garrido Reche, Cristina Medraño Viñas, Raúl Villaba, Pilar Cobeta, Eva Ureta, María Montiel, Nuria Mané, Nilda Martínez Castro, Gema Aleson Horno, Rebeca Alonso Salas, Carmen Bona García, Marta L Ferrer Ferrer, Marta Franco Abad, Ana C García Lecina, Julia Guillén Antón, Guillermo Hojas Gascón, Javier Peligro Deza, Leticia Pérez Pascual, Tomás Ruiz Garcés, Ana T Roberto Alcácer, Marek Badura, Eduardo Terrer Galera, Antonio Fernández Casares, Maria Carmen Martínez Fernández, Ángel Espinosa, Alfredo Abad-Gurumeta, Aarne Feldheiser, Francisco López Timoneda, Alix Zuleta-Alarcón, Sergio Bergese, J M Calvo-Vecino, J Ripollés-Melchor, M G Mythen, R Casans-Francés, A Balik, J P Artacho, E Martínez-Hurtado, A Serrano Romero, C Fernández Pérez, S Asuero de Lis, FEDORA Trial Investigators Group, Ana Tirado Errazquin, Cristina Gil Lapetra, Ane Abad Motos, Elena Garrido Reche, Cristina Medraño Viñas, Raúl Villaba, Pilar Cobeta, Eva Ureta, María Montiel, Nuria Mané, Nilda Martínez Castro, Gema Aleson Horno, Rebeca Alonso Salas, Carmen Bona García, Marta L Ferrer Ferrer, Marta Franco Abad, Ana C García Lecina, Julia Guillén Antón, Guillermo Hojas Gascón, Javier Peligro Deza, Leticia Pérez Pascual, Tomás Ruiz Garcés, Ana T Roberto Alcácer, Marek Badura, Eduardo Terrer Galera, Antonio Fernández Casares, Maria Carmen Martínez Fernández, Ángel Espinosa, Alfredo Abad-Gurumeta, Aarne Feldheiser, Francisco López Timoneda, Alix Zuleta-Alarcón, Sergio Bergese
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.
Clinical trial registration: ISRCTN93543537.
Keywords: Elective Surgical Procedures/adverse effects; Hemodynamics/physiology; Intraoperative/methods; Postoperative Complications/prevention & control; Prospective Studies.
Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.
Source: PubMed