跳至主要内容
临床试验/NCT03913403
NCT03913403Unknown不适用

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)

Intermountain Health Care, Inc.7 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2019年4月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
210
试验地点
7
主要终点
Left Ventricular Contractility at 24 hours

研究概览

简要总结

This ancillary study determines whether the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) [ClinicalTrials.gov Identifier: NCT03434028] treatment arms (restrictive fluids strategy vs. liberal fluid strategy) for early sepsis-induced hypotension are associated with differences in cardiac structure and function based on an echocardiogram at 24 hours after randomization. Secondarily, this ancillary study explores possible heterogeneity of treatment effect based on an echocardiogram performed shortly after randomization in CLOVERS.

详细描述

The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM) study is an ancillary study to CLOVERS, a parent multi-center, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The CLOVERS trial attempts to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension. This ancillary study obtains echocardiograms among CLOVERS-enrolled patients who consent to CLOVERS-STEM at baseline and 24 hours later (secondarily, this study also measures serum troponin levels at baseline and 24 hours) to pursue three aims: 1. Evaluate for differences in left ventricular global longitudinal strain at 24 hours after randomization between treatment arms; 2. Evaluate for differences in right ventricular end diastolic area to left ventricular end diastolic area ratio at 24 hours after randomization between treatment arms; 3. Explore possible heterogeneity of treatment effect based on baseline echocardiogram.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial

排除标准

  • Lack of Informed Consent for this Ancillary Study
  • Allergy to Ultrasound-Enhancing Agents

结局指标

主要结局

Left Ventricular Contractility at 24 hours

时间窗: 24 +/- 6 Hours

Left Ventricular Global Longitudinal Strain

Right Ventricular Structure at 24 hours

时间窗: 24 +/- 6 hours

Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio

Day 3 delta SOFA

时间窗: at 72 hours

Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores

次要结局

  • Right Ventricular Contractility at 24 hours(24 +/- 6 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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