Study of Treatment's Echocardiographic Mechanisms

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.
Brief Title
Study of Treatment's Echocardiographic Mechanisms
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
801-507-4607
Central Contact Email
valerie.aston@imail.org
Central Contact Role
Contact
Central Contact Phone
801-507-4607
Central Contact Email
carlos.barbagelata@imail.org
Completion Date
Completion Date Type
Estimated
Conditions
Sepsis
Eligibility 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
Inclusion Criteria
Inclusion Criteria:

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

Gender
All
Gender Based
false
Keywords
Fluid Management
Sepsis-Induced Hypotension
Vasopressors
Cardiac Contractility
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03913403
Org Class
Other
Org Full Name
Intermountain Health Care, Inc.
Org Study Id
1051075
Overall Status
Unknown status
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)
Primary Outcomes
Outcome Description
Left Ventricular Global Longitudinal Strain
Outcome Measure
Left Ventricular Contractility at 24 hours
Outcome Time Frame
24 +/- 6 Hours
Outcome Description
Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio
Outcome Measure
Right Ventricular Structure at 24 hours
Outcome Time Frame
24 +/- 6 hours
Outcome Description
Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores
Outcome Measure
Day 3 delta SOFA
Outcome Time Frame
at 72 hours
Secondary Outcomes
Outcome Description
Right Ventricular Longitudinal Strain
Outcome Time Frame
24 +/- 6 hours
Outcome Measure
Right Ventricular Contractility at 24 hours
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Study Population
Participants in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial with no allergy to ultrasound-enhancing agents
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michelle Gong
Investigator Email
mgong@montefiore.org
Investigator Phone
718-920-5464