一项关于脓毒症患者心脏超声表型的多中心前瞻性队列研究：一项多中心前瞻性队列试验的研究方案。

A multicenter prospective cohort study of cardiac ultrasound phenotypes in patients with sepsis: Study protocol for a multicenter prospective cohort trial.

作者信息

Zhang Hongxuan, Wang Xiaoting, Yin Wanhong, Zhang Hongmin, Liu Lixia, Pan Pan, Zhu Ying, Huang Wei, Xing Zhiqun, Yao Bo, Wang Cui, Lin Tianlai, Yu Rongguo, Shang Xiuling

机构信息

The Third Department of Critical Care Medicine, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fujian Provincial Center for Critical Care Medicine, Fujian Provincial Key Laboratory of Critical Care Medicine, Fuzhou, China.

Department of Critical Care Medicine, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.

出版信息

Front Med (Lausanne). 2022 Jul 27;9:938536. doi: 10.3389/fmed.2022.938536. eCollection 2022.

DOI:10.3389/fmed.2022.938536

PMID:35966841

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9363883/

Abstract

BACKGROUND

Sepsis-induced cardiomyopathy significantly increased the mortality of patients with sepsis. The diagnostic criteria for septic cardiomyopathy has not been unified, which brings serious difficulties to clinical treatment. This study aimed to provide evidence for the early identification and intervention in patients with sepsis by clarifying the relationship between the ultrasound phenotype of septic cardiomyopathy and the prognosis of patients with sepsis.

METHODS

This was a multicenter, prospective cohort study. The study population will consist of all eligible consecutive patients with sepsis or septic shock who meet the Sepsis 3.0 diagnostic criteria and were aged ≥18 years. Clinical data and echocardiographic measurements will be recorded within 2 h, at the 24th hour, at the 72nd hour, and on the 7th day after admission. The prevalence of each phenotype will be described as well, and their association with prognosis will be analyzed statistically.

DISCUSSION

To achieve early recognition, prevent reinjury, achieve precise treatment, and reduce mortality in patients with sepsis, it is important to identify septic cardiac alterations and classify the phenotypes at all stages of sepsis. First, there is a lack of studies on the prevalence of each phenotype in Chinese populations. Second, each phenotype and its corresponding prognosis are not clear. In addition, the prognosis of patients with normal cardiac ultrasound phenotypes vs. those with suppressed or hyperdynamic cardiac phenotypes is unclear. Finally, this study was designed to collect data at four specific timing, then the timing of occurrence, duration, changes over time, impact to outcomes of each phenotype will probably be found. This study is expected to establish a standard and objective method to assess the ultrasound phenotype of septic cardiomyopathy due to its advantages of visualization, non-invasiveness and reproducibility, and to provide more precise information for the hemodynamic management of septic patients. In addition, this research will promote the clinical application of critical care ultrasound, which will play an important role in medical education and make ultrasound the best method to assess cardiac changes in sepsis.

TRIAL REGISTRATION

https://clinicaltrials.gov/ct2/show/NCT05161104, identifier NCT05161104.

摘要

背景

脓毒症诱导的心肌病显著增加了脓毒症患者的死亡率。脓毒症性心肌病的诊断标准尚未统一，给临床治疗带来了严重困难。本研究旨在通过阐明脓毒症性心肌病的超声表型与脓毒症患者预后之间的关系，为脓毒症患者的早期识别和干预提供依据。

方法

这是一项多中心前瞻性队列研究。研究人群将包括所有符合脓毒症3.0诊断标准、年龄≥18岁的连续入选的脓毒症或脓毒症休克患者。临床数据和超声心动图测量将在入院后2小时、24小时、72小时和第7天记录。还将描述每种表型的患病率，并对其与预后的关联进行统计学分析。

讨论

为了实现脓毒症患者的早期识别、预防再次损伤、实现精准治疗并降低死亡率，在脓毒症的各个阶段识别脓毒症性心脏改变并对表型进行分类非常重要。首先，缺乏关于中国人群中每种表型患病率的研究。其次，每种表型及其相应的预后尚不清楚。此外，心脏超声表型正常的患者与心脏表型抑制或高动力型的患者的预后尚不清楚。最后，本研究设计在四个特定时间点收集数据，然后可能会发现每种表型的发生时间、持续时间、随时间的变化以及对结局的影响。由于其可视化、无创性和可重复性的优点，本研究有望建立一种评估脓毒症性心肌病超声表型标准化和客观的方法，并为脓毒症患者的血流动力学管理提供更精确的信息。此外，本研究将促进重症超声在临床中的应用，这将在医学教育中发挥重要作用，并使超声成为评估脓毒症心脏变化的最佳方法。