Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)
| Autor: | Ane Abad Motos, Julia Guillén Antón, Ana Tirado Errazquin, S. Asuero de Lis, Monty G. Mythen, Javier Ripollés-Melchor, Francisco López Timoneda, Sergio D. Bergese, A. Balik, Nuria Mané, Á. Espinosa, Eduardo Terrer Galera, Rubén Casans-Francés, Aarne Feldheiser, J.P. Artacho, A. Serrano Romero, Nilda Martínez Castro, Gema Aleson Horno, Alix Zuleta-Alarcon, J.M. Calvo-Vecino, Rebeca Alonso Salas, María Montiel, Marek Badura, Javier Peligro Deza, Marta Lucía Ferrer Ferrer, Alfredo Abad-Gurumeta, Ana Teresa Roberto Alcácer, Elena Garrido Reche, Cristina Gil Lapetra, Leticia Isabel Pérez Pascual, Raúl Villaba, Maria Carmen Martínez Fernández, Eugenio Martínez-Hurtado, Eva Ureta, Antonio Fernández Casares, Cristina Medraño Viñas, C. Fernández Pérez, Pilar Cobeta, Carmen Bona García, Guillermo Hojas Gascón, Marta Franco Abad, Ana Cristina García Lecina, Tomás Ruiz Garcés |
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| Rok vydání: | 2016 |
| Předmět: |
Male
Risk Mean arterial pressure Randomization Cardiotonic Agents Cardiac index law.invention 03 medical and health sciences 0302 clinical medicine Esophagus Postoperative Complications Randomized controlled trial 030202 anesthesiology law medicine Humans Vasoconstrictor Agents Prospective Studies Elective surgery Prospective cohort study Ultrasonography Interventional business.industry Hemodynamics 030208 emergency & critical care medicine Ultrasonography Doppler Middle Aged medicine.disease Clinical trial Anesthesiology and Pain Medicine Elective Surgical Procedures Anesthesia Fluid Therapy Female business Goals Kidney disease |
| Zdroj: | British journal of anaesthesia. 120(4) |
| ISSN: | 1471-6771 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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