以基线心脏指数为目标的腹部大手术高危患者的个性化血流动力学管理：随机单中心临床试验
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以基线心脏指数为目标的腹部大手术高危患者的个性化血流动力学管理：随机单中心临床试验
翻译：佟睿 编辑：冯玉蓉 审校：曹莹
背景：尽管进行了一些血液动力学治疗的临床试验，但对于接受腹部大手术的高危患者来说，最佳的术中血流动力学管理仍不清楚。我们验证了这一假设，即针对每位患者在休息时的基线心脏指数进行个性化血流动力学管理可降低术后并发症发生率。
方法：在这项单中心试验中，188名接受腹部大手术的高危患者被随机分为常规治疗或个性化血流动力学治疗两组，要求临床医生使用一种算法指导术中静脉液体输注和（或）多巴酚丁胺注射来维持个人基线心脏指数(在术前静息时测定)。主要指标是主要并发症(欧洲围术期临床指标定义)或手术后30天内死亡的综合结果。次要指标包括术后发病率(通过术后发病率调查评估)、住院时间、手术后90天内的死亡率，以及术后第3天后评估的神经认知功能。
结果：个性化管理组的主要指标发生率为29.8%(28/94名患者)，常规管理组为55.3%(52/94名患者)(相对危险度：0.54，95%CI：0.38~0.77；绝对风险降低：-25.5%，95%CI：-39.2%~-11.9%；P<0.001)。个性化管理组有1例患者在术后30天内死亡，而常规管理组有5例患者死亡(P=0.097)。在次要指标方面，两组之间并无临床相关的差异。
结论：在接受腹部大手术的高危患者中，与常规护理相比，个性化的血流动力学管理减少了术后30天内主要并发症或死亡的综合结果。
原始文献来源：Julia Y. Nicklas, Oliver Diener, Maximilian Leistenschneider, et al. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial.[J].Br J Anaesth, 2020 Aug ; 125 (2): 122-132。
Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial
Abstract
Background: Despite several clinical trials on haemodynamic therapy, the optimal intraoperative haemodynamic management for high-risk patients undergoing major abdominal surgery remains unclear. We tested the hypothesis that personalised haemodynamic management targeting each individual’s baseline cardiac index at rest reduces post-operative morbidity.
Methods: In this single-centre trial, 188 high-risk patients undergoing major abdominal surgery were randomised to either routine management or personalised haemodynamic management requiring clinicians to maintain personal baseline cardiac index (determined at rest preoperatively) using an algorithm that guided intraoperative i.v. fluid and/or dobutamine administration. The primary outcome was a composite of major complications (European Perioperative Clinical Outcome definitions) or death within 30 days of surgery. Secondary outcomes included postoperative morbidity (assessed by a postoperative morbidity survey), hospital length of stay, mortality within 90 days of surgery, and neurocognitive function assessed after postoperative Day 3.
Results: The primary outcome occurred in 29.8% (28/94) of patients in the personalised management group, compared with 55.3% (52/94) of patients in the routine management group (relative risk: 0.54, 95% confidence interval [CI]: 0.38 to 0.77; absolute risk reduction: -25.5%, 95% CI: -39.2% to -11.9%; P<0.001). One patient assigned to the personalised management group, compared with five assigned to the routine management group, died within 30 days after surgery (P=0.097). There were no clinically relevant differences between the two groups for secondary outcomes.
Conclusions: In high-risk patients undergoing major abdominal surgery, personalised haemodynamic management reduces a composite outcome of major postoperative complications or death within 30 days after surgery compared with routine care.
Clinical trial registration: NCT02834377.
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