Department of Anesthesiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Department of Anesthesiology and Intensive Care, Albert Schweitzer Hospital, Dordrecht, the Netherlands.
J Clin Anesth. 2021 Dec;75:110506. doi: 10.1016/j.jclinane.2021.110506. Epub 2021 Sep 15.
The potential of perioperative goal-directed therapy (PGDT) to improve outcome after high-risk abdominal surgery remains subject of debate. In particular, there is a need for large, multicenter trials focusing on relevant patient outcomes to confirm the evidence found in small, single center studies including minor complications in their composite endpoints. The present study therefore aims to investigate the effect of an arterial waveform analysis based PGDT algorithm on the incidence of major complications including mortality after high-risk abdominal surgery.
Prospective randomized controlled multicenter trial.
Operating theatres and Post-Anesthesia/Intensive Care units (PACU/ICU) of four tertiary hospitals in The Netherlands.
A total number of 482 patients undergoing elective, abdominal surgery that is considered high-risk due to the extent of the procedure and/or patient comorbidities.
Hemodynamic therapy using an age-specific PGDT algorithm including cardiac index (CI) and stroke volume variation (SVV) measurements during a 24-h perioperative period starting at induction of anesthesia.
The average number of major complications (including mortality) within 30 days after surgery, the number of minor complications, hospital and PACU/ICU length of stay (LOS), amounts of fluids and vasoactive medications used. Complications were graded using the Accordion severity grading system.
The average number of major complications per patient was 0.79 (PGDT group) versus 0.69 (control group) (p = 0.195). There were no statistically significant differences in the number of minor complications, hospital LOS, PACU/ICU LOS, or grading of complications. Patients in the PGDT group received more fluids intraoperatively, more dobutamine intra- and postoperatively, while patients in the control group received more phenylephrine during the operation.
PGDT based on a CI and SVV driven algorithm did not result in improved outcomes after high-risk abdominal surgery.
Netherlands Trial Registry: NTR3380.
围手术期目标导向治疗（PGDT）改善高危腹部手术后结局的潜力仍存在争议。特别是需要大型、多中心试验，重点关注相关患者结局，以确认在小型、单中心研究中发现的证据，包括将次要并发症纳入复合终点。因此，本研究旨在调查基于动脉波形分析的 PGDT 算法对高危腹部手术后主要并发症（包括死亡率）发生率的影响。
前瞻性随机对照多中心试验。
荷兰四家三级医院的手术室和麻醉后/重症监护病房（PACU/ICU）。
总共 482 名接受择期腹部手术的患者，由于手术范围和/或患者合并症，这些手术被认为是高危手术。
麻醉诱导后 24 小时内，使用特定年龄的 PGDT 算法进行血流动力学治疗，包括心指数（CI）和每搏量变异（SVV）测量。
术后 30 天内平均主要并发症（包括死亡率）数量、次要并发症数量、住院和 PACU/ICU 住院时间（LOS）、使用的液体和血管活性药物量。并发症使用 Accordion 严重程度分级系统进行分级。
每组患者的平均主要并发症（PGDT 组为 0.79，对照组为 0.69）（p=0.195）。次要并发症数量、住院 LOS、PACU/ICU LOS 或并发症分级无统计学差异。PGDT 组患者术中接受更多液体，术后接受更多多巴酚丁胺，而对照组患者术中接受更多去氧肾上腺素。
基于 CI 和 SVV 驱动算法的 PGDT 并未改善高危腹部手术后的结局。
荷兰临床试验注册中心：NTR3380。
