Kaufmann Kai B, Baar Wolfgang, Rexer Judith, Loeffler Thomas, Heinrich Sebastian, Konstantinidis Lukas, Buerkle Hartmut, Goebel Ulrich
Department of Anaesthesiology and Critical Care, Medical Center - University of Freiburg, Hugstetter Strasse 55, 79106, Freiburg, Germany.
Faculty of Medicine, University of Freiburg, Freiburg, Germany.
BMC Anesthesiol. 2018 Jun 6;18(1):63. doi: 10.1186/s12871-018-0526-4.
The bone cement implantation syndrome (BCIS) is a frequent and potentially disastrous intraoperative complication in patients undergoing cemented hip arthroplasty. Several risk factors have been identified, however randomized controlled trials to reduce the incidence of BCIS are still pending. We hypothesized that goal-directed hemodynamic therapy guided by esophageal Doppler monitoring (EDM) may reduce the incidence of BCIS in a randomized, controlled parallel-arm trial.
After approval of the local ethics committee, 90 patients scheduled for cemented hip arthroplasty at the Medical Center - University of Freiburg were randomly assigned to either standard hemodynamic management or goal-directed therapy (GDT) guided by an esophageal Doppler monitoring-based algorithm. The primary endpoint was the incidence of overall BCIS including grade 1-3 after cementation of the femoral stem. Secondary endpoints included cardiac function, length of hospital stay and postoperative complications.
Ninety patients were finally analyzed. With regards to the primary endpoint, the overall incidence of BCIS showed no difference between the GDT and control group. Compared to the control group, patients of the GDT group showed a higher cardiac index before and after bone cement implantation (2.7 vs. 2.2 [l●min●m]; 2.8 vs. 2.4 [l●min●m]; P = 0.003, P = 0.042), whereas intraoperative amount of fluids and mean arterial pressure did not differ.
The implementation of a specific hemodynamic goal-directed therapy did not reduce the overall incidence of BCIS in patients undergoing cemented hip arthroplasty.
This randomized clinical two-arm parallel study was approved by the local Ethics Committee, Freiburg, Germany [EK 160/15, PI: U. Goebel] and registered in the German Clinical Trials Register ( DRKS No. 00008778 , 16th of June, 2015).
骨水泥植入综合征（BCIS）是接受骨水泥型髋关节置换术患者中常见且可能导致灾难性后果的术中并发症。已确定了多个风险因素，然而，旨在降低BCIS发生率的随机对照试验仍在进行中。我们假设在一项随机对照平行组试验中，由食管多普勒监测（EDM）引导的目标导向血流动力学治疗可能降低BCIS的发生率。
经当地伦理委员会批准，90例计划在弗莱堡大学医学中心接受骨水泥型髋关节置换术的患者被随机分配至标准血流动力学管理组或由基于食管多普勒监测的算法引导的目标导向治疗（GDT）组。主要终点是股骨柄骨水泥固定后1-3级总体BCIS的发生率。次要终点包括心功能、住院时间和术后并发症。
最终分析了90例患者。关于主要终点，GDT组和对照组之间BCIS的总体发生率无差异。与对照组相比，GDT组患者在骨水泥植入前后的心脏指数较高（2.7对2.2 [l●min●m]；2.8对2.4 [l●min●m]；P = 0.003，P = 0.042），而术中液体量和平均动脉压无差异。
实施特定的目标导向血流动力学治疗并不能降低接受骨水泥型髋关节置换术患者BCIS的总体发生率。
这项随机临床双臂平行研究经德国弗莱堡当地伦理委员会批准[EK 160/15，PI：U. Goebel]，并在德国临床试验注册中心注册（DRKS编号00008778，2015年6月16日）。
