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Study of Treatment's Echocardiographic Mechanisms

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ClinicalTrials.gov Identifier: NCT03913403
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : June 20, 2019
Sponsor:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sepsis 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.

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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




Primary Outcome Measures :
  1. Left Ventricular Contractility at 24 hours [ Time Frame: 24 +/- 6 Hours ]
    Left Ventricular Global Longitudinal Strain

  2. Right Ventricular Structure at 24 hours [ Time Frame: 24 +/- 6 hours ]
    Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio

  3. Day 3 delta SOFA [ Time Frame: at 72 hours ]
    Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores


Secondary Outcome Measures :
  1. Right Ventricular Contractility at 24 hours [ Time Frame: 24 +/- 6 hours ]
    Right Ventricular Longitudinal Strain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913403


Contacts
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Contact: Valerie Aston 801-507-4607 valerie.aston@imail.org
Contact: Carlos Barbagelata, MS 801-507-4607 carlos.barbagelata@imail.org

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

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03913403     History of Changes
Other Study ID Numbers: 1051075
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: A de-identified version of the analytic data-set will be available for use 3 years after the primary publication.
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.
URL: https://biolincc.nhlbi.nih.gov/home/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intermountain Health Care, Inc.:
Fluid Management
Sepsis-Induced Hypotension
Vasopressors
Cardiac Contractility
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vasoconstrictor Agents