Clinical Trial

. 2025 Jun 5:14:100421.

doi: 10.1016/j.bjao.2025.100421. eCollection 2025 Jun.

Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial

Sean Coeckelenbergh^{1

2}, Amelie Delaporte³, Damien Rousseleau⁴, Jacques De Montblanc⁵, Stephanie Roullet⁶, Joanna Ramadan⁶, Bernard Cholley⁷, Alexandre Sitbon⁸, Emmanuel Weiss⁹, Maria-Christina Kassab¹⁰, Sylvain Diop¹⁰, Elsa Manzi¹¹, Marco Pustetto¹², Guillaume Porta Bonette¹³, Pierre Gregoire Guinot¹⁴, Philippe Guerci¹⁵, Domien Vanhonacker¹⁶, Francois Martin Carrier¹⁷, Brenton Alexander¹⁸, Joseph Rinehart¹, David Boldt³, Tristan Grogan¹⁹, Maxime Cannesson³, Jacques Duranteau⁵, Lamiae Grimaldi²⁰, Bruno Pereira²¹, Alexandre Joosten³

Affiliations

¹ Department of Anesthesiology & Perioperative Care, University of California, Irvine, Irvine, CA, USA.
² Outcomes Research Consortium, Cleveland, OH, USA.
³ Department of Anesthesiology & Perioperative Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
⁴ Department of Anesthesiology and Intensive Care Department, Claude Huriez Hospital, Lille University Hospital, Lille, France.
⁵ Department of Anesthesiology and Intensive Care, Bicêtre Hospital, Le Kremlin Bicêtre, France.
⁶ Department of Anesthesiology and Intensive Care, Paris-Saclay University, Paul Brousse Hospital, Villejuif, France.
⁷ Department of Anesthesiology, Intensive Care Perioperative Medicine, Hôpital Européen Georges Pompidou, Paris Cité University, Paris, France.
⁸ Department of Anesthesiology and Critical Care, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.
⁹ Department of Anesthesiology and Critical Care, Beaujon Hospital, Paris Cité University, Paris, France.
¹⁰ Department of Anesthesiology, Marie Lannelongue Hospital, Le Plessis-Robinson, France.
¹¹ Department of Anesthesiology, Institut Mutualiste Montsouris, Paris, France.
¹² Department of Anesthesia and Intensive Care, Grenoble-Alpes University Hospital, Grenoble, France.
¹³ Department of Anesthesiology and Perioperative Medicine, Pierre-Paul Riquet Hospital, Toulouse, France.
¹⁴ Department of Anesthesiology and Critical Care Medicine, Dijon University Medical Centre, University of Burgundy and Franche-Comté, Dijon, France.
¹⁵ Department of Anesthesiology, Nancy University Hospital, Nancy, France.
¹⁶ Department of Anesthesiology, Perioperative and Pain Medicine, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, Brussels, Belgium.
¹⁷ Department of Anesthesiology, Montreal University Hospital, Montreal, QC, Canada.
¹⁸ Department of Anesthesiology, University of California, San Diego, La Jolla, CA, USA.
¹⁹ Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
²⁰ Clinical Research Unit, Paris-Saclay University, Bicêtre Hospital, Le Kremlin Bicêtre, France.
²¹ Clinical Research Unit, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.

PMID: 40529718
PMCID: PMC12173124
DOI: 10.1016/j.bjao.2025.100421

Clinical Trial

Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial

Sean Coeckelenbergh et al. BJA Open. 2025.

. 2025 Jun 5:14:100421.

doi: 10.1016/j.bjao.2025.100421. eCollection 2025 Jun.

Authors

Affiliations

¹ Department of Anesthesiology & Perioperative Care, University of California, Irvine, Irvine, CA, USA.
² Outcomes Research Consortium, Cleveland, OH, USA.
³ Department of Anesthesiology & Perioperative Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
⁴ Department of Anesthesiology and Intensive Care Department, Claude Huriez Hospital, Lille University Hospital, Lille, France.
⁵ Department of Anesthesiology and Intensive Care, Bicêtre Hospital, Le Kremlin Bicêtre, France.
⁶ Department of Anesthesiology and Intensive Care, Paris-Saclay University, Paul Brousse Hospital, Villejuif, France.
⁷ Department of Anesthesiology, Intensive Care Perioperative Medicine, Hôpital Européen Georges Pompidou, Paris Cité University, Paris, France.
⁸ Department of Anesthesiology and Critical Care, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.
⁹ Department of Anesthesiology and Critical Care, Beaujon Hospital, Paris Cité University, Paris, France.
¹⁰ Department of Anesthesiology, Marie Lannelongue Hospital, Le Plessis-Robinson, France.
¹¹ Department of Anesthesiology, Institut Mutualiste Montsouris, Paris, France.
¹² Department of Anesthesia and Intensive Care, Grenoble-Alpes University Hospital, Grenoble, France.
¹³ Department of Anesthesiology and Perioperative Medicine, Pierre-Paul Riquet Hospital, Toulouse, France.
¹⁴ Department of Anesthesiology and Critical Care Medicine, Dijon University Medical Centre, University of Burgundy and Franche-Comté, Dijon, France.
¹⁵ Department of Anesthesiology, Nancy University Hospital, Nancy, France.
¹⁶ Department of Anesthesiology, Perioperative and Pain Medicine, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, Brussels, Belgium.
¹⁷ Department of Anesthesiology, Montreal University Hospital, Montreal, QC, Canada.
¹⁸ Department of Anesthesiology, University of California, San Diego, La Jolla, CA, USA.
¹⁹ Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
²⁰ Clinical Research Unit, Paris-Saclay University, Bicêtre Hospital, Le Kremlin Bicêtre, France.
²¹ Clinical Research Unit, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.

PMID: 40529718
PMCID: PMC12173124
DOI: 10.1016/j.bjao.2025.100421

Abstract

Background: Inappropriate fluid administration can impact patient outcome. Intraoperative advanced haemodynamic monitoring coupled with a treatment protocol based on stroke volume optimisation can help determine the appropriate timing for fluid boluses. Although recommended by several anaesthesia societies, this strategy is rarely implemented because protocols are complex and compliance is often poor. The Acumen Assisted Fluid Management (AFM) software is a decision support system that uses machine learning to predict fluid responsiveness and individualise fluid therapy. AFM reportedly predicts fluid responsiveness better than clinicians, decreases preload-dependent states, and improves both macro- and microcirculatory variables. The goal of this international multicentre stepped-wedge cluster randomised trial is to test whether implementing AFM during high-risk surgery improves patient outcome.

Methods: The trial is ongoing in 16 academic hospitals in France, Belgium, Canada, and the USA. All centres (clusters) deliver routine care (control arm) at the start of the study and crossed over (one way) to AFM-guided fluid therapy (intervention arm). The time when different centres switch to AFM is randomised by an independent statistician. At the end of the trial, all centres will cross over to the intervention group. The primary outcome is a composite of major complications and death 30 days after surgery that will be analysed as intention-to-treat. A total of 2000 patients are required to detect a relative 20% differences in the primary outcome between groups.

Conclusions: This trial is powered to provide evidence on whether implementing AFM is effective in reducing postoperative complications in high-risk patients after high-risk abdominal surgery.

Clinical trial registration: NCT06011187.

Keywords: acute kidney injury; complications; fluid therapy; goal directed therapy; haemodynamic monitoring; haemodynamic optimisation; high-risk surgery; mortality; outcome; surgery.

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Conflict of interest statement

SC, DV, PGG, AS, and PG received honoraria from Edwards Lifesciences for delivering lectures. BC received funding for an investigator-initiated research proposal, lecturing fees for presentations at industry-sponsored symposia and honoraria for participation to advisory boards from Edwards Lifesciences, lecturing fees for presentations at industry-sponsored symposia and honoraria for participation to advisory boards (Nordic Pharma), and lecturing fees for presentations at industry-sponsored symposia (AOP Health). PGG received fees for lectures from Edwards, Vygon, and AOP and is a consultant for Abbot. MC has ownership interest in Sironis, and Sironis has developed a closed-loop fluid system whose software is used in the Assisted Fluid Management System (Edwards Lifesciences, Irvine, CA, USA). The other authors declare that they have no conflicts of interest.

Figures

**Figure 1**
Stepped-wedge study design of the PEFLA trial. Considering the number of participating centres (16 centres) and the duration of this study (24 months), it was proposed to fix eight intervals of 3 months each. The randomisation will involve seven steps, each of them including two to three centres.

See this image and copyright information in PMC

References

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Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial

Affiliations

Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

Associated data

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous