Abstract：
BACKGROUND: The dynamic arterial elastance (EaDyn), calculated as pulse pressure variation divided by stroke volume variation, has been studied as a predictor of vasopressor weaning. However, its potential as a haemodynamic tool for tapering off vasopressors in patients with sepsis remains unexplored. Therefore, our study aimed to assess whether using EaDyn for weaning vasopressor support could reduce the duration of vasopressor support in patients with sepsis.
METHODS: This pragmatic single-centre controlled clinical trial will take place at Fundación Santa Fe de Bogotá, Colombia. Adult patients diagnosed with septic shock according to the sepsis-3 criteria and a Sequential Organ Failure Assessment score ≥4 will be included. A total of 114 patients (57 per group) will undergo conventional critical care monitoring, and the weaning of vasopressor support will be initiated based on the EaDyn or mean arterial pressure (MAP), depending on the assigned group. EaDyn will be estimated based on the measurements obtained from a PiCCO device connected to a PulsioFlex Monitoring Platform (PULSION Medical Systems SE, Feldkirchen, Germany). Our primary outcome is the difference in vasopressor support duration between the EaDyn and MAP groups.Participants and statisticians performing the statistical analysis will be blinded to the group allocation. Dependent and independent variables will be analysed through univariate and multivariate statistical tests. Since we will perform three repeated measurements for analysis, we will implement a Bonferroni post hoc correction. Additionally, Cox regression and Kaplan-Meier analyses will be conducted to address objectives related to time.
BACKGROUND: This study was approved by the Ethics Committee at Fundación Santa Fe de Bogotá (CCEI-16026-2024). Written informed consent will be obtained from all participants. The results will be disseminated through publication in peer-reviewed journals and presentations at national and international events.
BACKGROUND: NCT06118775.
METHODS: This pragmatic single-centre controlled clinical trial will take place at Fundación Santa Fe de Bogotá, Colombia. Adult patients diagnosed with septic shock according to the sepsis-3 criteria and a Sequential Organ Failure Assessment score ≥4 will be included. A total of 114 patients (57 per group) will undergo conventional critical care monitoring, and the weaning of vasopressor support will be initiated based on the EaDyn or mean arterial pressure (MAP), depending on the assigned group. EaDyn will be estimated based on the measurements obtained from a PiCCO device connected to a PulsioFlex Monitoring Platform (PULSION Medical Systems SE, Feldkirchen, Germany). Our primary outcome is the difference in vasopressor support duration between the EaDyn and MAP groups.Participants and statisticians performing the statistical analysis will be blinded to the group allocation. Dependent and independent variables will be analysed through univariate and multivariate statistical tests. Since we will perform three repeated measurements for analysis, we will implement a Bonferroni post hoc correction. Additionally, Cox regression and Kaplan-Meier analyses will be conducted to address objectives related to time.
BACKGROUND: This study was approved by the Ethics Committee at Fundación Santa Fe de Bogotá (CCEI-16026-2024). Written informed consent will be obtained from all participants. The results will be disseminated through publication in peer-reviewed journals and presentations at national and international events.
BACKGROUND: NCT06118775.
摘要：
背景：动态动脉弹性(EaDyn)，计算为脉压变化除以冲程容积变化，已被研究作为血管加压药断奶的预测因子。然而,其作为减少脓毒症患者血管加压药的血流动力学工具的潜力仍未得到探索.因此,我们的研究旨在评估在脓毒症患者中使用EaDyn进行撤机加压药支持是否可以减少加压药支持的持续时间.
方法：这项务实的单中心对照临床试验将在圣达菲波哥大基金会进行，哥伦比亚。将包括根据脓毒症-3标准和序贯器官衰竭评估评分≥4诊断为脓毒性休克的成年患者。共有114名患者(每组57名)接受常规重症监护,并且根据EaDyn或平均动脉压（MAP）开始撤药。取决于分配的组。EaDyn将根据从连接到PulsioFlex监测平台(PULSIONMedicalSystemsSE,费尔德基兴,德国)。我们的主要结果是EaDyn组和MAP组之间血管加压药支持持续时间的差异。进行统计分析的参与者和统计人员将对小组分配视而不见。将通过单变量和多变量统计检验分析因变量和自变量。由于我们将进行三次重复测量进行分析，我们将实施Bonferroni事后更正。此外,将进行Cox回归和Kaplan-Meier分析以解决与时间相关的目标。
背景：这项研究得到了圣达菲波哥大基金会伦理委员会的批准（CCEI-16026-2024）。将获得所有参与者的书面知情同意书。结果将通过在同行评审的期刊上发表和在国家和国际活动上的演讲来传播。
背景：NCT06118775。
方法：这项务实的单中心对照临床试验将在圣达菲波哥大基金会进行，哥伦比亚。将包括根据脓毒症-3标准和序贯器官衰竭评估评分≥4诊断为脓毒性休克的成年患者。共有114名患者(每组57名)接受常规重症监护,并且根据EaDyn或平均动脉压（MAP）开始撤药。取决于分配的组。EaDyn将根据从连接到PulsioFlex监测平台(PULSIONMedicalSystemsSE,费尔德基兴,德国)。我们的主要结果是EaDyn组和MAP组之间血管加压药支持持续时间的差异。进行统计分析的参与者和统计人员将对小组分配视而不见。将通过单变量和多变量统计检验分析因变量和自变量。由于我们将进行三次重复测量进行分析，我们将实施Bonferroni事后更正。此外,将进行Cox回归和Kaplan-Meier分析以解决与时间相关的目标。
背景：这项研究得到了圣达菲波哥大基金会伦理委员会的批准（CCEI-16026-2024）。将获得所有参与者的书面知情同意书。结果将通过在同行评审的期刊上发表和在国家和国际活动上的演讲来传播。
背景：NCT06118775。
