Clinical trial NCT03913403: Study of Treatment's Echocardiographic Mechanisms
Official title: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: Fluid Management
Sepsis-Induced Hypotension
Vasopressors
Cardiac Contractility
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Montefiore Medical Center
name: Oregon Health and Science University
name: Vanderbilt University Medical Center
name: Wake Forest University Health Sciences
name: Harborview Injury Prevention and Research Center
First posted: 2019-04-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Left Ventricular Contractility at 24 hours
timeFrame: 24 +/- 6 Hours
measure: Right Ventricular Structure at 24 hours
timeFrame: 24 +/- 6 hours
measure: Day 3 delta SOFA
timeFrame: at 72 hours
Secondary outcomes:
measure: Right Ventricular Contractility at 24 hours
timeFrame: 24 +/- 6 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences Center
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Samuel Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: