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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Montefiore Medical Center | OTHER |
| Oregon Health and Science University | OTHER |
| Vanderbilt University Medical Center |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Participants will receive 2 ECHO's and 2 Blood Draws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECHO | Procedure | Echocardiogram at baseline and 24 hours later |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricular Contractility at 24 hours | Right Ventricular Longitudinal Strain | 24 +/- 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial with no allergy to ultrasound-enhancing agents
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie Aston | Contact | 801-507-4607 | valerie.aston@imail.org | |
| Carlos Barbagelata, MS | Contact | 801-507-4607 | carlos.barbagelata@imail.org |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Brown, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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.
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A de-identified version of the analytic data-set will be available for use 3 years after the primary publication.
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.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
| Wake Forest University Health Sciences | OTHER |
| Harborview Injury Prevention and Research Center | OTHER |
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| Blood Draw |
| Procedure |
Blood Draw for Troponin Levels - 5ml at baseline and 24 hours later |
|
| Montefiore Medical Center | Not yet recruiting | The Bronx | New York | 10467 | United States |
|
| Wake Forest Baptist Medical Center | Not yet recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Oregon Health Sciences Center | Not yet recruiting | Portland | Oregon | 97239 | United States |
|
| Vanderbilt University | Not yet recruiting | Nashville | Tennessee | 37235 | United States |
|
| Intermountain Medical Center | Recruiting | Murray | Utah | 84107 | United States |
|
| Harborview Medical Center | Not yet recruiting | Seattle | Washington | 98104 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |