Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Sepsis
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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...

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.

Tracking Information

NCT #
NCT03913403
Collaborators
  • Beth Israel Deaconess Medical Center
  • Montefiore Medical Center
  • Oregon Health and Science University
  • Vanderbilt University Medical Center
  • Wake Forest University Health Sciences
  • Harborview Injury Prevention and Research Center
Investigators
Principal Investigator: Samuel Brown, MD Intermountain Health Care, Inc.