Hemodynamic Management guided by the Hypotension Prediction Index in Abdominal Surgery: A Multicenter Randomized Clinical Trial.

IF 9.1 1区 医学 Q1 ANESTHESIOLOGY Anesthesiology Pub Date : 2025-01-02 DOI:10.1097/ALN.0000000000005355
Javier Ripollés-Melchor, José L Tomé-Roca, Andrés Zorrilla-Vaca, César Aldecoa, María J Colomina, Eva Bassas-Parga, Juan V Lorente, Alicia Ruiz-Escobar, Laura Carrasco-Sánchez, Marc Sadurni-Sarda, Eva Rivas, Jaume Puig, Elizabeth Agudelo-Montoya, Sabela Del Rio-Fernández, Daniel García-López, Ana B Adell-Pérez, Antonio Guillen, Rocío Venturoli-Ojeda, Bartolomé Fernández-Torres, Ane Abad-Motos, Irene Mojarro, José L Garrido-Calmaestra, Jesús Fernanz-Antón, Ana Pedregosa-Sanz, Luisa Cueva-Castro, Miren A Echevarria-Correas, Montserrat Mallol, María M Olvera-García, Rosalía Navarro-Pérez, Paula Fernández-Valdés-Bango, Javier García-Fernández, Ángel V Espinosa, Hussein Abu Khudair, Ángel Becerra-Bolaños, Yolanda Díez-Remesal, María A Fuentes-Pradera, Miguel A Valbuena-Bueno, Begoña Quintana-Villamandos, Jordi Llorca-García, Ignacio Fernández-López, Álvaro Ocón-Moreno, Sandra L Martín-Infantes, Javier M Valiente-Lourtau, Marta Amelburu-Egoscozabal, Hugo Rivera-Ramos, Alfredo Abad-Gurumeta, Manuel I Monge-García
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Abstract

Background: Postoperative acute kidney injury (AKI) after major abdominal surgery leads to poor outcomes. The Hypotension Prediction Index (HPI) may aid in managing intraoperative hemodynamic instability. This study assessed if HPI-guided therapy reduces moderate-to-severe AKI incidence in moderate-to-high-risk elective abdominal surgery patients.

Methods: This multicenter randomized trial was conducted from October 2022 to February 2024 across 28 hospitals evaluating HPI-guided management compared to a wide range of real-world hemodynamic approaches. 917 patients (≥65 years or >18 years with ASA status >II) undergoing moderate-to-high-risk elective abdominal surgery were included in the intention-to-treat analysis. HPI-guided management triggered interventions when the HPI exceeded 80, using fluids and/or vasopressors/inotropes based on hemodynamic data. The primary outcome was the incidence of moderate-to-severe AKI within the first 7 days after surgery. Secondary outcomes included overall complications, the need for renal replacement therapy, duration of hospital stay, and 30-day mortality.

Results: Median age was 71 years (IQR, 65-77) in the HPI group and 70 years (IQR, 63-76) in standard care group. ASA status III/IV was 58.3% (268/459) in the HPI group and 57.9% (263/458) in standard care group. The incidence of moderate-to-severe AKI was 6.1% (28/459) in the HPI group and 7.0% (32/458) in the standard care group (RR 0.89, 95% 0.54-1.49; P=0.66). Overall complications occurred in 31.9% (146/459) of the HPI group and 29.7% (136/458) of the standard care group (RR 1.08, 95% CI 0.85-1.37; P = 0.52). The incidence of renal replacement therapy did not differ between groups. Median length of hospital stay was 6 days (IQR, 4-10) in both groups. The 30-day mortality was 1.1% (5/459) in the HPI group versus 0.9% (4/458) in standard care group (RR 1.35, 95% CI 0.36-5.10; P = 0.66).

Conclusions: HPI-guided hemodynamic therapy did not reduce the incidence of postoperative AKI or overall complications compared to standard care.

Clinicaltrialsgov identifier: NCT05569265.

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以低血压预测指数为指导的腹部手术血流动力学管理:一项多中心随机临床试验。
背景:腹部大手术后急性肾损伤(AKI)会导致不良预后。低血压预测指数(HPI)有助于控制术中血流动力学不稳定。本研究评估了 HPI 指导下的治疗是否能降低中高危择期腹部手术患者中度至重度 AKI 的发生率:这项多中心随机试验于 2022 年 10 月至 2024 年 2 月在 28 家医院进行,评估 HPI 指导下的管理与各种实际血液动力学方法的比较。917名接受中高危择期腹部手术的患者(年龄≥65岁或大于18岁,ASA状态大于II级)被纳入意向治疗分析。HPI 指导下的管理在 HPI 超过 80 时触发干预,根据血流动力学数据使用液体和/或血管加压素/肌注。主要结果是术后7天内中重度AKI的发生率。次要结果包括总体并发症、肾脏替代治疗需求、住院时间和30天死亡率:HPI组的中位年龄为71岁(IQR,65-77),标准护理组为70岁(IQR,63-76)。HPI组的ASA III/IV状态为58.3%(268/459),标准护理组为57.9%(263/458)。中重度 AKI 发生率在 HPI 组为 6.1%(28/459),标准护理组为 7.0%(32/458)(RR 0.89,95% 0.54-1.49;P=0.66)。HPI组31.9%(146/459)和标准护理组29.7%(136/458)的患者出现了总体并发症(RR 1.08,95% CI 0.85-1.37;P=0.52)。肾脏替代治疗的发生率在各组之间没有差异。两组的中位住院时间均为 6 天(IQR,4-10)。HPI组的30天死亡率为1.1%(5/459),而标准护理组为0.9%(4/458)(RR 1.35,95% CI 0.36-5.10;P = 0.66):结论:与标准护理相比,HPI指导下的血液动力学治疗并未降低术后AKI或总体并发症的发生率:NCT05569265。
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来源期刊
Anesthesiology
Anesthesiology 医学-麻醉学
CiteScore
10.40
自引率
5.70%
发文量
542
审稿时长
3-6 weeks
期刊介绍: With its establishment in 1940, Anesthesiology has emerged as a prominent leader in the field of anesthesiology, encompassing perioperative, critical care, and pain medicine. As the esteemed journal of the American Society of Anesthesiologists, Anesthesiology operates independently with full editorial freedom. Its distinguished Editorial Board, comprising renowned professionals from across the globe, drives the advancement of the specialty by presenting innovative research through immediate open access to select articles and granting free access to all published articles after a six-month period. Furthermore, Anesthesiology actively promotes groundbreaking studies through an influential press release program. The journal's unwavering commitment lies in the dissemination of exemplary work that enhances clinical practice and revolutionizes the practice of medicine within our discipline.
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