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Abstract
Introduction 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 and analysis 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.
Ethics and dissemination 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.
Trial registration number NCT06118775.
- INTENSIVE & CRITICAL CARE
- Clinical Trial
- Adult intensive & critical care
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X @jorgeialvarado
Contributors JIAS, AVM-N, YRC-B, MVS-R and AFMS contributed to the conception and design of the study. JIAS, AVM-N and AFMS will be responsible for enrolling study participants and ensuring adherence to protocol guidelines. During the implementation phase, all authors will collaboratively conduct randomisation and allocation procedures to maintain impartiality and accuracy. Throughout the follow-up period, AVM-N and AFMS will actively engage in patient monitoring and data collection to ensure the integrity of the study. JIAS will lead the drafting of the final manuscript, synthesising findings and interpretations. JIAS, AVM-N, YRC-B, MVS-R and AFMS played pivotal roles in the critical revision of the manuscript, offering valuable insights and enhancements. JIAS is responsible for the overall content as guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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