Study of Treatment's Echocardiographic Mechanisms

• Conditions: Sepsis
• Interventions: Procedure: ECHO; Procedure: Blood Draw

• Registration Number: NCT03913403
• Lead Sponsor: Intermountain Health Care, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-12
• Study Start: 2019-04-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Blood Draw	Participants will receive 2 ECHO's and 2 Blood Draws
Intervention	ECHO	Participants will receive 2 ECHO's and 2 Blood Draws

Primary Outcome Measures

Name	Time	Method
Left Ventricular Contractility at 24 hours	24 +/- 6 Hours	Left Ventricular Global Longitudinal Strain
Right Ventricular Structure at 24 hours	24 +/- 6 hours	Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio
Day 3 delta SOFA	at 72 hours	Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores

Secondary Outcome Measures

Name	Time	Method
Right Ventricular Contractility at 24 hours	24 +/- 6 hours	Right Ventricular Longitudinal Strain

Trial Locations

Locations (7)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Oregon Health Sciences Center; 🇺🇸 Portland, Oregon, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States