Study of Treatment's Echocardiographic Mechanisms

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Procedure: ECHO; Procedure: Blood Draw

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 Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Carlos Barbagelata, MS; Phone Number: 801-507-4607; Email: carlos.barbagelata@imail.org
• Study Contact Backup: Name: Valerie Aston; Phone Number: 801-507-4607; Email: valerie.aston@imail.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Somnath Bose, MD
  • New York
    • Bronx, New York, United States, 10467
      • Not yet recruiting
      • Montefiore Medical Center
      • Contact: Michelle Gong, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Not yet recruiting
      • Wake Forest Baptist Medical Center
      • Contact: Lane Smith, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
      • Oregon Health Sciences Center
      • Contact: Akram Khan, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Not yet recruiting
      • Vanderbilt University
      • Contact: Wesley Self, MD
      • Contact: Deepak Gupta, MD
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Medical Center
      • Contact: Carlos Barbagelata, MS; Phone Number: 801-507-4607; Email: carlos.barbagelata@imail.org
      • Sub-Investigator: Sarah Beesley, MD
      • Contact: Samuel Brown, MD; Phone Number: 801-507-6556; Email: Samuel.brown@imail.org
      • Principal Investigator: Samuel Brown, MD
      • Sub-Investigator: Elliotte Hirshberg, MD
      • Sub-Investigator: Michael Lanspa, MD
      • Sub-Investigator: Lindsay Leither
  • Washington
    • Seattle, Washington, United States, 98104
      • Not yet recruiting
      • Harborview Medical Center
      • Contact: Catherine Hough, MD
      • Contact: Nicholas Johnson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial with no allergy to ultrasound-enhancing agents

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; Participants will receive 2 ECHO's and 2 Blood Draws	Procedure: ECHO; Echocardiogram at baseline and 24 hours later; Procedure: Blood Draw; Blood Draw for Troponin Levels - 5ml at baseline and 24 hours later

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right Ventricular Contractility at 24 hours	Right Ventricular Longitudinal Strain	24 +/- 6 hours

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Beth Israel Deaconess Medical Center; Montefiore Medical Center; Wake Forest University Health Sciences; Oregon Health and Science University; Vanderbilt University Medical Center; Harborview Injury Prevention and Research Center

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Vasopressors; Fluid Management; Sepsis-Induced Hypotension; Cardiac Contractility
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: 1051075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be collected electronically and stored at the Coordinating Center at Intermountain Medical Center. A de-identified version of the analytic data-set will be available for use 3 years after the primary publication. Data can be accessed at that point via the National Heart, Lung and Blood Institute (NHLBI) Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) data repository.
• IPD Sharing Time Frame: A de-identified version of the analytic data-set will be available for use 3 years after the primary publication.
• IPD Sharing Access Criteria: Investigators who complete the appropriate registrations with the Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) will have access to the de-identified analytic dataset as per BioLINCC policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No