Fuhrer Hannah, Günther Albrecht, Zinke Jan, Niesen Wolf-Dirk
Department of Neurology, Albert Ludwig University of Freiburg, Freiburg, Germany.
Department of Neurology, Friedrich Schiller University Jena, Jena, Germany.
Front Neurol. 2017 Aug 10;8:402. doi: 10.3389/fneur.2017.00402. eCollection 2017.
In unsuccessful vessel recanalization, clinical outcome of acute stroke patients depends on early improvement of penumbral perfusion. So far, mean arterial blood pressure (MAP) is the target hemodynamic parameter. However, the correlations of MAP to cardiac output (CO) and cerebral perfusion are volume state dependent. In severe subarachnoid hemorrhage, optimizing CO leads to a reduction of delayed ischemic neurological deficits and improvement of clinical outcome. This study aims to investigate the effect of standard versus advanced cardiac monitoring with optimization of CO on the clinical outcome in patients with large ischemic stroke.
The OPTIMAL study is a prospective, multicenter, open, into two arms (1:1) randomized, controlled trial. : sample sizes of 150 for each treatment group (300 in total) ensure an 80% power to detect a difference of 16% of a dichotomized level of functional clinical outcome at 3 months at a significance level of 0.05. : the primary endpoint is the functional outcome at 3 months. The secondary endpoints include functional outcome at 6 months follow-up, and complications related to hemodynamic monitoring and therapies.
The results of this trial will provide data on the safety and efficacy of advanced hemodynamic monitoring on clinical outcome.
The trial was approved by the leading ethics committee of Freiburg University, Germany (438/14, 2015) and the local ethics committees of the participating centers. The study is performed in accordance with the Declaration of Helsinki and the guidelines of Good Clinical Practice. It is registered in the German Clinical Trial register (DRKS; DRKS00007805). Dissemination will include submission to peer-reviewed professional journals and presentation at congresses. Hemodynamic monitoring may be altered in a specific stroke patient cohort if the study shows that advanced monitoring is safe and improves the functional outcome.
在血管再通失败的情况下，急性卒中患者的临床结局取决于半暗带灌注的早期改善。到目前为止，平均动脉血压（MAP）是目标血流动力学参数。然而，MAP与心输出量（CO）和脑灌注的相关性取决于容量状态。在严重蛛网膜下腔出血中，优化CO可减少延迟性缺血性神经功能缺损并改善临床结局。本研究旨在探讨标准与高级心脏监测并优化CO对大面积缺血性卒中患者临床结局的影响。
OPTIMAL研究是一项前瞻性、多中心、开放性、双臂（1:1）随机对照试验。每个治疗组的样本量为150例（共300例），确保在0.05的显著性水平下有80%的把握度检测出3个月时二分法功能临床结局水平相差16%。主要终点是3个月时的功能结局。次要终点包括6个月随访时的功能结局以及与血流动力学监测和治疗相关的并发症。
本试验结果将提供关于高级血流动力学监测对临床结局的安全性和有效性的数据。
该试验已获得德国弗莱堡大学主要伦理委员会（438/14, 2015）以及参与中心的当地伦理委员会的批准。本研究按照《赫尔辛基宣言》和良好临床实践指南进行。它已在德国临床试验注册中心（DRKS；DRKS00007805）注册。传播将包括提交给同行评审的专业期刊以及在大会上展示。如果研究表明高级监测安全且能改善功能结局，那么在特定的卒中患者队列中血流动力学监测可能会改变。
