NCT03913403

Study of Treatment's Echocardiographic Mechanisms

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Sepsis

Interventions

Type	Name	Description
PROCEDURE	ECHO	Echocardiogram at baseline and 24 hours later
PROCEDURE	Blood Draw	Blood Draw for Troponin Levels - 5ml at baseline and 24 hours later

Timeline

• Start date: 2019-04-30
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2019-04-12
• Last updated: 2021-02-10

Locations

7 sites across 1 country: United States