دورية أكاديمية
أعرض في EDS

Efficacy and safety of dynamic arterial elastance for weaning vasopressor support in septic shock patients: a randomised controlled trial protocol.

التفاصيل البيبلوغرافية
العنوان: Efficacy and safety of dynamic arterial elastance for weaning vasopressor support in septic shock patients: a randomised controlled trial protocol.
المؤلفون: Alvarado Sánchez JI; Critical Care Unit, Fundación Santa Fe de Bogotá, Bogotá, Colombia jialvarados@unal.edu.co.; Department of Physiology Sciences, Faculty of Medicine, Universidad Nacional de Colombia, Bogotá, Colombia., Montañez-Nariño AV; Critical Care Unit, Fundación Santa Fe de Bogotá, Bogotá, Colombia., Cárdenas-Bolivar YR; Critical Care Unit, Fundación Santa Fe de Bogotá, Bogotá, Colombia., Stozitzky-Ríos MV; Critical Care Unit, Fundación Santa Fe de Bogotá, Bogotá, Colombia., Mora-Salamanca AF; Critical Care Unit, Fundación Santa Fe de Bogotá, Bogotá, Colombia.
المصدر: BMJ open [BMJ Open] 2024 Aug 07; Vol. 14 (8), pp. e086388. Date of Electronic Publication: 2024 Aug 07.
نوع المنشور: Journal Article; Clinical Trial Protocol
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Shock, Septic*/drug therapy , Shock, Septic*/physiopathology , Vasoconstrictor Agents*/therapeutic use, Humans ; Randomized Controlled Trials as Topic ; Stroke Volume ; Male ; Colombia ; Female ; Arterial Pressure/drug effects ; Critical Care/methods ; Adult
مستخلص: 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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: Adult intensive & critical care; Clinical Trial; INTENSIVE & CRITICAL CARE
سلسلة جزيئية: ClinicalTrials.gov NCT06118775
المشرفين على المادة: 0 (Vasoconstrictor Agents)
تواريخ الأحداث: Date Created: 20240808 Date Completed: 20240808 Latest Revision: 20240918
رمز التحديث: 20240918
مُعرف محوري في PubMed: PMC11404246
DOI: 10.1136/bmjopen-2024-086388
PMID: 39117412
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2024-086388