腹部手术中低血压预测指数指导下的血流动力学管理：一项多中心随机临床试验
Hemodynamic Management Guided by the Hypotension Prediction Index in Abdominal Surgery: A Multicenter Randomized Clinical Trial.
作者信息
Ripollés-Melchor Javier, Tomé-Roca José L, Zorrilla-Vaca Andrés, Aldecoa César, Colomina María J, Bassas-Parga Eva, Lorente Juan V, Ruiz-Escobar Alicia, Carrasco-Sánchez Laura, Sadurni-Sarda Marc, Rivas Eva, Puig Jaume, Agudelo-Montoya Elizabeth, Del Rio-Fernández Sabela, García-López Daniel, Adell-Pérez Ana B, Guillen Antonio, Venturoli-Ojeda Rocío, Fernández-Torres Bartolomé, Abad-Motos Ane, Mojarro Irene, Garrido-Calmaestra José L, Fernanz-Antón Jesús, Pedregosa-Sanz Ana, Cueva-Castro Luisa, Echevarria-Correas Miren A, Mallol Montserrat, Olvera-García María M, Navarro-Pérez Rosalía, Fernández-Valdés-Bango Paula, García-Fernández Javier, Espinosa Ángel V, Abu Khudair Hussein, Becerra-Bolaños Ángel, Díez-Remesal Yolanda, Fuentes-Pradera María A, Valbuena-Bueno Miguel A, Quintana-Villamandos Begoña, Llorca-García Jordi, Fernández-López Ignacio, Ocón-Moreno Álvaro, Martín-Infantes Sandra L, Valiente-Lourtau Javier M, Amelburu-Egoscozabal Marta, Rivera-Ramos Hugo, Abad-Gurumeta Alfredo, Monge-García Manuel I
机构信息
Infanta Leonor University Hospital, Madrid, Spain; Universidad Complutense de Madrid, Madrid, Spain; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care, Madrid, Spain.
Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care, Madrid, Spain; Department of Anesthesia, Virgen de las Nieves University Hospital, Granada, Spain.
出版信息
Anesthesiology. 2025 Apr 1;142(4):639-654. doi: 10.1097/ALN.0000000000005355. Epub 2025 Jan 2.
BACKGROUND
Postoperative acute kidney injury (AKI) after major abdominal surgery leads to poor outcomes. The Hypotension Prediction Index (HPI; Edwards Lifesciences, USA) may aid in managing intraoperative hemodynamic instability. This study assessed whether 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. A total of 917 patients (65 yr or older or older than 18 yr with American Society of Anesthesiologists Physical Status greater than 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 yr (interquartile range, 65 to 77) in the HPI group and 70 yr (interquartile range, 63 to 76) in standard care group. American Society of Anesthesiologists Physical Status III/IV was 58.3% (268 of 459) in the HPI group and 57.9% (263 of 458) in standard care group. The incidence of moderate-to-severe AKI was 6.1% (28 of 459) in the HPI group and 7.0% (32 of 458) in the standard care group (risk ratio, 0.89; 95% CI, 0.54 to 1.49; P = 0.66). Overall complications occurred in 31.9% (146 of 459) of the HPI group and 29.7% (136 of 458) of the standard care group (risk ratio, 1.08; 95% CI, 0.85 to 1.37; P = 0.52). The incidence of renal replacement therapy did not differ between groups. Median length of hospital stay was 6 days (interquartile range, 4 to 10) in both groups. The 30-day mortality was 1.1% (5 of 459) in the HPI group versus 0.9% (4 of 458) in standard care group (risk ratio, 1.35; 95% CI, 0.36 to 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.
背景
腹部大手术后的术后急性肾损伤（AKI）会导致不良预后。低血压预测指数（HPI；美国爱德华生命科学公司）可能有助于管理术中血流动力学不稳定。本研究评估了HPI指导的治疗是否能降低中高危择期腹部手术患者中重度AKI的发生率。
方法
本多中心随机试验于2022年10月至2024年2月在28家医院进行，评估HPI指导的管理与多种实际血流动力学方法相比的效果。共有917例接受中高危择期腹部手术的患者（年龄65岁及以上或年龄大于18岁且美国麻醉医师协会身体状况分级大于II级）纳入意向性分析。当HPI超过80时，HPI指导的管理会触发干预措施，根据血流动力学数据使用液体和/或血管加压药/正性肌力药。主要结局是术后第1个7天内中重度AKI的发生率。次要结局包括总体并发症、肾脏替代治疗的需求、住院时间和30天死亡率。
结果
HPI组的中位年龄为71岁（四分位间距，65至77岁），标准治疗组为70岁（四分位间距，63至76岁）。HPI组中美国麻醉医师协会身体状况分级为III/IV级的比例为58.3%（459例中的268例），标准治疗组为57.9%（458例中的263例）。HPI组中重度AKI的发生率为6.1%（459例中的28例），标准治疗组为7.0%（458例中的32例）（风险比，0.89；95%CI，0.54至1.49；P = 0.66）。HPI组总体并发症发生率为31.9%（459例中的146例），标准治疗组为29.7%（458例中的136例）（风险比，1.08；95%CI，0.85至1.37；P = 0.52）。两组间肾脏替代治疗的发生率无差异。两组的中位住院时间均为6天（四分位间距，4至10天）。HPI组的30天死亡率为1.1%（459例中的5例），标准治疗组为0.9%（458例中的4例）（风险比，1.35；95%CI，0.36至5.10；P = 0.66）。
结论
与标准治疗相比，HPI指导的血流动力学治疗并未降低术后AKI的发生率或总体并发症发生率。
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