一种基于动态弹性的方案用于指导腹部大手术术中液体管理：一项随机临床试验。

A dynamic elastance-based protocol to guide intra-operative fluid management in major abdominal surgery: A randomised clinical trial.

作者信息

Russo Andrea, Aceto Paola, Cascarano Laura, Menga Luca S, Romanò Bruno, Carelli Simone, Console Edoardo, Pugliese Francesca, Cambise Chiara, Fiorillo Claudio, Alfieri Sergio, Antonelli Massimo, Sollazzi Liliana, Dell'Anna Antonio M

机构信息

From the Department of Anaesthesiology, Intensive Care and Emergency Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy (AR, PA, LC, LSM, BR, SC, EC, FP, CC, MA, LS, AMDA), the Department of Basic Biotechnological Science, Intensive and Peri-operative Clinics, Università Cattolica del Sacro Cuore, Rome, Italy (PA, CF, SA, MA, LA).

出版信息

Eur J Anaesthesiol. 2025 Aug 1;42(8):727-736. doi: 10.1097/EJA.0000000000002162. Epub 2025 Mar 11.

DOI:10.1097/EJA.0000000000002162

PMID:40070308

Abstract

BACKGROUND

Arterial hypotension during major surgery is related to postoperative complications and mortality. Both fluids and vasopressors increase blood pressure (BP) by inducing different physiological response. We devised a protocol which relies on dynamic arterial elastance (Ea dyn ) to guide BP optimisation during major abdominal surgery, and tested its effectiveness on tissue perfusion.

OBJECTIVE

To explore if an Ea dyn -based optimisation protocol could affect lactate levels, fluid administration, and postoperative clinical complications.

DESIGN

Randomised open-label clinical trial.

SETTING

High-volume tertiary care centre for pancreatic surgery.

PATIENTS

From 58 patients scheduled for cephalic duodenopancreatectomy 46 were eligible for the study.

MAIN OUTCOMES AND MEASURES

The primary endpoint was the lactate value one hour after extubation. Secondary endpoints were fluid balance, intra-operative hypotension and postoperative complications. In the control group, hypotension (mean arterial pressure < 65 mmHg) was treated based on stroke volume variation (SVV) while in the experimental group the treatment was based on assessment of dynamic arterial elastance (Ea dyn group). Patient demographic and pre-operative laboratory data were recorded. All haemodynamic data, including oxygen delivery and consumption, were recorded at four time points: after intubation (T0), after fascia opening (T1), after fascia closing (T2) and one hour after extubation (T3).

RESULTS

The patients were 70 [63 to 76] years and 15 (33%) were ASA 3. Lactate levels at T3 were similar between the control and Ea dyn groups. Oxygen consumption was higher in the Ea dyn group at T3, and lactate had a significant percentage decrease from T2 to T3: median [IQR], -24.5 [-30 to -14] vs. 0 [-24 to 7.6]%, P = 0.004). Those in Ea dyn group received more vasopressors and had a lower fluid balance at T3: 2700 [2100 to 3800] vs. 2200 [1060 to 3000] ml, P = 0.020). There were no significant differences either in postoperative complications or hospital stay.

CONCLUSIONS

A protocol including Ea dyn to treat hypotension did not reduce lactate after major abdominal surgery, but it was associated with a significant reduction in fluid balance and increase in oxygen consumption.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05187273.

摘要

背景

大手术期间的动脉低血压与术后并发症及死亡率相关。液体和血管升压药均通过引发不同的生理反应来升高血压（BP）。我们设计了一种方案，该方案依靠动态动脉弹性（Ea dyn）来指导腹部大手术期间的血压优化，并测试其对组织灌注的有效性。

目的

探讨基于Ea dyn的优化方案是否会影响乳酸水平、液体输注量及术后临床并发症。

设计

随机开放标签临床试验。

地点

胰腺手术量大的三级医疗中心。

患者

58例计划行胰十二指肠切除术的患者中，46例符合研究条件。

主要结局和测量指标

主要终点是拔管后1小时的乳酸值。次要终点是液体平衡、术中低血压和术后并发症。在对照组中，低血压（平均动脉压<65 mmHg）根据每搏量变异（SVV）进行治疗，而在实验组中，治疗基于动态动脉弹性评估（Ea dyn组）。记录患者的人口统计学和术前实验室数据。所有血流动力学数据，包括氧输送和消耗，在四个时间点记录：插管后（T0）、筋膜切开后（T1）、筋膜关闭后（T2）和拔管后1小时（T3）。

结果

患者年龄为70[63至76]岁，15例（33%）为美国麻醉医师协会（ASA）3级。T3时对照组和Ea dyn组的乳酸水平相似。Ea dyn组在T3时的氧消耗较高，且乳酸从T2到T3有显著百分比下降：中位数[四分位间距]，-24.5[-30至-14]%对0[-24至7.6]%，P = 0.004）。Ea dyn组在T3时接受更多血管升压药且液体平衡较低：2700[2100至3800]对2200[1060至30oo]ml，P = 0.020）。术后并发症或住院时间均无显著差异。