调查术中决策支持引导的液体治疗干预对高危腹部手术患者术后结局的有效性：一项国际多中心楔形步进集群随机实施试验的方案

BJA open Pub Date : 2025-06-01 DOI:10.1016/j.bjao.2025.100421

Sean Coeckelenbergh , Amelie Delaporte , Damien Rousseleau , Jacques De Montblanc , Stephanie Roullet , Joanna Ramadan , Bernard Cholley , Alexandre Stibon , Emmanuel Weiss , Maria-Christina Kassab , Sylvain Diop , Elsa Manzi , Marco Pustetto , Guillaume Porta Bonette , Pierre Gregoire Guinot , Philippe Guerci , Domien Vanhonacker , Francois Martin Carrier , Brenton Alexander , Joseph Rinehart , Alexandre Joosten

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引用次数: 0

摘要

背景：适当的液体给药会影响患者的预后。术中先进的血流动力学监测与基于卒中容量优化的治疗方案相结合，可以帮助确定适当的输液时机。虽然有几个麻醉学会推荐，但这种策略很少被实施，因为方案复杂，依从性往往很差。Acumen辅助流体管理（AFM）软件是一个决策支持系统，它使用机器学习来预测流体反应并个性化流体治疗。据报道，AFM比临床医生更能预测流体反应，减少预负荷依赖状态，并改善宏观和微循环变量。这项国际多中心楔形聚类随机试验的目的是测试在高风险手术中实施AFM是否能改善患者的预后。方法该试验正在法国、比利时、加拿大和美国的16家学术医院进行。所有中心（集群）在研究开始时提供常规护理（对照组），并交叉（单向）到afm引导的液体治疗（干预组）。不同的中心切换到AFM的时间是由一个独立的统计学家随机决定的。在试验结束时，所有中心都将转为干预组。主要结局是主要并发症和术后30天死亡的综合结果，将作为意向治疗进行分析。总共需要2000名患者来检测组间主要结果的相对20%的差异。结论本试验旨在为实施AFM是否能有效减少高危腹部手术后高危患者的术后并发症提供证据。临床试验注册号nct06011187。

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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

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.