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Randomized Controlled Trial Multicenter Study
Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial.
- Sandra Funcke, Götz Schmidt, Alina Bergholz, Pilar Argente Navarro, Gonzalo Azparren Cabezón, Silvia Barbero-Espinosa, Oscar Diaz-Cambronero, Fabian Edinger, Nuria García-Gregorio, Marit Habicher, Gerd Klinkmann, Christian Koch, Alina Kröker, Thomas Mencke, Victoria Moral García, Amelie Zitzmann, Susanne Lezius, Amra Pepić, Daniel I Sessler, Michael Sander, Sebastian A Haas, Daniel A Reuter, and Bernd Saugel.
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
- Br J Anaesth. 2024 Aug 1; 133 (2): 277287277-287.
BackgroundIt is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery.MethodsIn three German and two Spanish centres, high-risk patients having elective major open abdominal surgery were randomised to cardiac index-guided therapy to maintain optimised postinduction cardiac index (cardiac index at which pulse pressure variation was <12%) during and for the first 8 h after surgery using intravenous fluids and dobutamine or to routine care. The primary outcome was the incidence of a composite outcome of moderate or severe complications within 28 days after surgery.ResultsWe analysed 318 of 380 enrolled subjects. The composite primary outcome occurred in 84 of 152 subjects (55%) assigned to cardiac index-guided therapy and in 77 of 166 subjects (46%) assigned to routine care (odds ratio: 1.87, 95% confidence interval: 1.03-3.39, P=0.038). Per-protocol analyses confirmed the results of the primary outcome analysis.ConclusionsMaintaining optimised postinduction cardiac index during and for the first 8 h after surgery did not reduce, and possibly increased, the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. Clinicians should not strive to maintain optimised postinduction cardiac index during and after surgery in expectation of reducing complications.Clinical Trial RegistrationNCT03021525.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.
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