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Journal of Clinical Monitoring and Computing

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01-12-2018 | Original Research

Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial

Authors: Marc Lilot, Amandine Bellon, Marine Gueugnon, Marie-Christine Laplace, Bruno Baffeleuf, Pauline Hacquard, Felicie Barthomeuf, Camille Parent, Thomas Tran, Jean-Luc Soubirou, Philip Robinson, Lionel Bouvet, Olivia Vassal, Jean-Jacques Lehot, Vincent Piriou

Published in: Journal of Clinical Monitoring and Computing | Issue 6/2018

Abstract

An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case–control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min⁻¹ m⁻², p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.

Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013.

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Title: Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial
Authors: Marc Lilot
Amandine Bellon
Marine Gueugnon
Marie-Christine Laplace
Bruno Baffeleuf
Pauline Hacquard
Felicie Barthomeuf
Camille Parent
Thomas Tran
Jean-Luc Soubirou
Philip Robinson
Lionel Bouvet
Olivia Vassal
Jean-Jacques Lehot
Vincent Piriou
Publication date: 01-12-2018
Publisher: Springer Netherlands
Published in: Journal of Clinical Monitoring and Computing / Issue 6/2018
Print ISSN: 1387-1307
Electronic ISSN: 1573-2614
DOI: https://doi.org/10.1007/s10877-018-0106-7

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Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial

Abstract

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

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